Sr. Associate Compliance

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

• 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 - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

Sun Pharma Vision:  Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines

Sun Pharmaceutical Industries Ltd. (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.

Our Code of Conduct

Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.

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The Sr. Associate Compliance (Investigations, CCR, PQCs) 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.

• Collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations.
• Work directly on technical investigations relating to product quality complaints.
• Provide verbal and written responses/resolutions to customers regarding Product Quality Complaints or product inquiries.
• Conducts Investigations of Site Incidents/Deviations and Product Quality Complaints in TrackWise system and provides final review.
• Ensures a robust deviation management program is executed to ensure effective root cause analysis and corrective and preventative action identified and completed.
• Reviews and approves Change controls, CAPA and Global CAPA and monitors the effectiveness of CAPA.
• Ensure adequate tools used during the investigations.
• Participate in all manufacturing/Quality control related to the investigation.
• Generate Summaries for the investigations; Trending of Site Incidents; Product Quality Complaints; Out of Specifications; Out of Trends on monthly; Quarterly and annually basis.
• Ensure effectiveness check of Corrective and Preventive actions. 
• Ensure adequate risk assessments are performed using tools like Failure Mode Effect Analysis.
• Manage investigations related to complaints, planned, unplanned deviations, FAR, Quality alerts and batch failures. Assists in ensuring FDA Readiness Plan for the facility. Provides support for all regulatory audits, internal/external inspections, and other audits. Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, internal audits, etc.
• Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
• Identifies compliance issues and supports the implementation changes for constant improvements. 
• Supports adherence to SOPs and policies and assists in ensuring that procedures reflect current practice. Create new SOP’s and revise the existing SOP’s as applicable.
• Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications.
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques.
• Perform analysis of Annual Product Review (APR) statistics reported for each product; investigate any OOT testing results identified in the product APR; and provide written summary for inclusion in the APR.
• 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.
• Drive projects to improve the QMS for compliance, efficiency, or corporate needs.
• Author/revise standard operating procedures (SOPs) and test methods, as required.
• Act as the Site IPC (Investigation Program Champion).
• QRB (Quality Review Board)/IRB (Investigation Review Board) Coordinator.
• TrackWise Site coordinator: Ensuring all users of Trackwise are trained in the roles.
• GQS/GSOP implementation coordinator: Ensuring the site is in compliance with Sun’s Global processes
• Other duties as assigned.

Qulifications

• Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
• Working knowledge of cGMPs, GLPs
• Strong knowledge of instrumental and wet analytical chemistry
• Strong knowledge of microbiology testing
• Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
• Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture

• Demonstrated ability and knowledge of QMS and driving investigations to completion

• Expertise level of understanding of GMPs
• Expertise in software applications such as: Word, Excel, Office, Windows, PowerPoint, Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System), etc.
• Knowledge of project management principles, practices, techniques and tools
• Excellent interpersonal and communication skills, both written and verbal
• Strong organizational and time management skills; must have ability to prioritize and manage multiple assignments simultaneously while working independently or with others as needed
• A self-starter with a hands-on approach and a can-do attitude.
• Strong working knowledge of MS Office software