SUN PHARMA

Job Summary

Overall responsibilities include Operations Management for Aseptic and Dermatologic product lines, as well as oversight of Plant Services, Manufacturing & Validation Engineering, and Materials/warehousing. Overall responsibility for the inspection, maintenance, repair and servicing of plant equipment, buildings and facilities.

Area Of Responsibility

• Coordinate production, Materials/warehousing, plant engineering and related support functions to maximize productivity, quality and profitability while minimizing cost and working within an established budget
• Responsible for identifying staffing and needs for training, developing and motivating subordinates in materials management, plant operations, facility maintenance and all system, process and equipment validations
• Prioritize production schedules based on inventory requirements, new product introduction, equipment efficiency and material supply
• Responsible for the inspection, maintenance, repair and servicing of plant equipment, buildings and facilities, ensuring building codes and safety standards are maintained
• Assure maintenance of materials, parts and specialized tools to prevent work stoppage; and, through subordinates, assure maintenance projects by employees or private contractors conform to specifications and contracts
• Interface with other Site Leaders to formulate and integrate manufacturing objectives to achieve overall company goals
• Hire, train and evaluate performance of subordinate personnel
• Achieve continuous improvement in final product yields for manufactured products and promote quality improvement activities
• Responsible for activities involved with building security
• Ensure that personnel are trained, per cGMP regulations, for all aspects of the jobs they are performing
• Other duties as assigned

Education and Job Qualification

• B.S. in Engineering or other science required; Master’s degree preferred
• Minimum 10+ years in pharmaceutical manufacturing or compliance, with 5-8 years management experience

Experience

• Direct experience and training on industry standards for aseptic manufacturing, engineering and validation requirements
• Strong team management skills who exhibits a high level of initiative and self-motivation
• Strong computer skills
• Ability to plan, prioritize and organize diversified workload
• Excellent verbal, written and interpersonal communication skills
• Strong knowledge of FDA cGMP, SOP’s and ICH, and EU standards
• Detail-oriented and strong record keeping skills

Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $4.5B. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines to more than 100 countries across the globe. In the U.S., we are among the top 10 generic pharmaceutical companies and are ranked second by prescriptions in the generic dermatology market. We manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates. Our broad portfolio of more than 2000 high quality molecules covers multiple dosage forms, including tablets, capsules, injectables, inhalers, ointments, creams, and liquids. Our presence in emerging markets and the developing world enables our teams to cross-sell and build brands with ease. Sunology is our core values: Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Sun Pharmaceuticals offer a wide range of benefits including:

· Generous PTO + 11 paid vacation days

· Highly subsidized Medical, Dental, Vision Benefits

· Health Savings Account (HSA), Flexible Spending Account (FSA)

· Prescription Drug Coverage

· Telehealth and Behavior Health Services

· Income Protection – Short Term and Long Term Disability Benefits

· Retirement Benefits – 4% company 401k Match on Day One (100% vesting immediately)

· Group Life Insurance

· Wellness Programs

· Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

SUN PHARMA

This role will manage the development, establishment, and maintenance of Quality Systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards for our 100 person state-of-the-art facility in Billerica, MA.

Area Of Responsibility

• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Design, plan, implement, and manage documentation programs, policies, and procedures that support company objectives and regulatory requirements
• Supervise the QA Documentation department in the creation, issuance, maintenance, archiving, and storage of cGMP and cGXP controlled documentation and records
• Manage electronic document processing, retrieval, and distribution systems (EDMS), electronic learning management system (LMS), electronic Quality Management System (TrackWise), etc.
• Administer document and system access rights and revision control to ensure security of system and integrity of master documents
• Lead Monthly Quality Review Board (QRB) meetings, Quality Investigation Board (QIB)
• Supervise the creation of an annual training calendar and other training initiatives at the site
• Provide expertise and input to other functional areas affecting controlled documents and records
• Assist with FDA and other compliance audits including corporate audits.
• Facilitate and follow up with stakeholders with regard to responses to audit observations
• Prepare annual internal audit schedule and perform execution of same
• Oversee site vendor management program including performing annual vendor risk assessment
• Oversee harmonization efforts between corporate and plant Quality procedures and policies
• Provide QA review of Annual Product Reviews (APRs) to identify trends and recommend CAPA as needed
• Provide QA review of quality events such as unplanned/planned deviations and change controls
• Participate in investigation team efforts to determine root cause for critical quality events and recommend appropriate CAPA
• Develop presentation materials for upper management to disseminate on the topics of quality issues, QMS
• initiatives, and related projects
• Participate in Regional Quality related projects and initiatives, acting as an ambassador between corporate and plant
• Issuance of Quality Alerts, FAR/Recall as per internal procedures
• Other duties as assigned

Education and Job Qualification

• B.S. in chemistry or related scientific field
• Minimum ten (10) years of related experience in pharmaceutical (manufacturing) environment, biotech industry, Quality Assurance, Quality Control and/or production, or FDA regulated industry.

Experience

• Strong working knowledge of a Quality Management System (QMS) and adherence to 21 CFR Parts 210, 211; aseptic drug manufacturing experience a plus
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and training projects in a fast paced environment, in an efficient manner
• Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization
• Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments
• Experience in developing and managing various types of training initiatives expected
• Excellent administrative & organization skills
• Strong presentation and MS Power Point Skills
• Positive attitude; values others and works well independently and in a team environment
• Excellent verbal, written and interpersonal communication skills
• Works under minimal supervision following established procedures along with own judgment.
• Expert knowledge of electronically based Quality Systems
• Working knowledge of pharmaceutical and medical device documentation and change controls
• Experience with continuous improvement programs and project management skills
• Working knowledge of applicable domestic and international standards and regulations

Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility. Integrity. Passion. Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.

Sun Pharmaceuticals offer a wide range of benefits including:

· Generous PTO + 11 paid vacation days

· Highly subsidized Medical, Dental, Vision Benefits

· Health Savings Account (HSA), Flexible Spending Account (FSA)

· Prescription Drug Coverage

· Telehealth and Behavior Health Services

· Income Protection – Short Term and Long Term Disability Benefits

· Retirement Benefits – 4% company 401k Match on Day One (100% vesting immediately)

· Group Life Insurance

· Wellness Programs

· Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

SUN PHARMA

Sun Pharmaceuticals Industries Inc. manufactures markets, and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current manufacturing capabilities allow Sun Pharma to develop products across most therapeutic categories.

At Sun Pharma we believe our people are an invaluable asset. Our culturally diverse workforce is one of our biggest strengths, along with the rich experience they bring across varied skill-sets. We are proud that our global workforce is bound by our common values: Humility. Integrity. Passion. Innovation.

This position is of critical importance, as this individual will be responsible for leading the development of Commercial operational processes, strategy, and analytics. The overall objective of the role is to lead the design and execution of primary research that spans multiple products and indications as a contributor for the Market Insights and Analytics team. He/she will be responsible for delivering high quality business insights for Sun’s current and future product decision making. This individual will work closely with marketing teams to design strategic research plans to address business questions, inform strategy development and support portfolio planning.

Responsibilities include vendor management, development, planning and management of primary market research studies, integration of secondary data insights and presentation of insights to cross-functional teams. She/He will serve as an internal consultant to marketing by providing meaningful and actionable strategic insights, thereby helping key internal stakeholders make informed strategic decisions. This individual will collaborate closely with key internal stakeholders (Marketing, Sales, Commercial Effectiveness, IT, Patient Services, Legal, Compliance) to accomplish the responsibilities of this role.

Responsibilities:

• Be a strategic partner to the commercial teams to lead the design and delivery of high quality, actionable business insights by conducting market research projects in support of pipeline, prelaunch, and inline products
• Lead in-depth situation analyses and SWOT (strengths, weaknesses, opportunities, and threats) of relevant disease areas in support of the annual brand planning process
• Lead strategic insights workshops to convert data from primary or secondary market research projects to insights and to answer Key Business Questions (KBQs)
• Co-lead annual forecasting cycle working closely with forecasting team
• Create and manage budgets for the brands

Education and Qualifications:

• Bachelors in Marketing, Communications, or related field
• At least 4+ years of pharmaceutical/biotech commercial experience
• Knowledge of secondary data analytics & forecasting, and consulting experience are a plus
• Experience working with third party data such as IQVIA, Symphony Health, other claims and EMR
• Additional experience in Consulting, Managed care, Marketing, or sales is a plus.
• Exceptional oral and written communication skills, and be well versed in Microsoft Office applications

Sun Pharmaceuticals offer a wide range of benefits including:

· Generous PTO + 11 paid vacation days

· Highly subsidized Medical, Dental, Vision Benefits

· Health Savings Account (HSA), Flexible Spending Account (FSA)

· Prescription Drug Coverage

· Telehealth and Behavior Health Services

· Income Protection – Short Term and Long Term Disability Benefits

· Retirement Benefits – 4% company 401k Match on Day One (100% vesting immediately)

· Group Life Insurance

· Wellness Programs

· Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Taro employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

SUN PHARMA