Sr. Associate, Compliance (Qa / Pqr)

We are looking for an experienced QA professional well-versed in PQR within commercial pharmaceutical manufacturing. This is an on-site role.

Job Summary

The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.

Area Of Responsibility

• Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
• Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
• Author/revise standard operating procedures (SOPs) and test methods, as required
• Other duties as assigned
• Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
• Manage electronic Quality Management System (TrackWise)
• Work directly on technical investigations relating to Product Quality Complaints
• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
• Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs

Education and Job Qualification

• Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner
• Superior internal and external customer service/people skills
• B.S. in chemistry or related scientific field

Experience Required

• Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc…
• Strong working knowledge of MS Office software
• Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
• Working knowledge of cGMPs, GLPs
• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
• Strong knowledge of microbiology testing
• Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
• Minimum 6 - 8+ years related experience in a pharmaceutical manufacturing environment
• Strong knowledge of instrumental and wet analytical chemistry

COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!

• Telehealth and Behavior Health Services
• Generous PTO + 11 paid holidays
• Income Protection – Short Term and Long Term Disability Benefits
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods
• Retirement Benefits - 401(k) 4% company match on day one (100% vesting immediately)
• Wellness Programs
• Prescription Drug Coverage
• Medical, Dental, Vision Benefits (individual plans starting at $50/mo)
• Group Life Insurance
• Health Savings Account (HSA), Flexible Spending Account (FSA) + $600 company contribution

Sun Pharmaceutical Industries Inc. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world. 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.

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