Senior Manager - Quality Assurance

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Manager - Quality Assurance

Job Description

The role is responsible for ensuring end-to-end Quality Assurance compliance for APIs and intermediates, aligning with GMP and regulatory requirements. It involves oversight of batch release/rejection, approval of specifications and procedures, and effective management of quality systems including deviations, OOS, change controls, and risk assessments. The position plays a key role in validation, stability review, product quality review, and audit readiness, while ensuring timely closure of quality issues and maintaining high standards of compliance. The incumbent also leads internal audits, vendor evaluations, and supports customer and regulatory inspections, ensuring robust responses and continuous quality improvement.

• Releasing or rejecting all APIs including intermediates
• Ensuring the compliance of all the systems as per GMP requirement
• Approving all specifications and master production instructions
• Investigation and closure of all deviations & OOS
• Approving all procedures affecting quality of RM/IM/API
• Conducting self-inspections and internal audit
• Conduction vendor evaluation
• Review of changes that potentially impact intermediates or API Quality
• Reviewing of validation protocols and reports
• Investigation of quality related customer complaints and returned goods
• Review of preventive maintenance and calibration of equipment's
• To execute Risk Assessment Activity
• Review of stability data
• Performing product quality review
• Facing customer and regulatory audits
• Ensuring proper responses to the customer and regulatory queries
• Checking of QA procedure
• In absence of Head-QA, will be responsible for QA related activities

Audit Readiness, Batch Record Review, Quality Management Systems (QMS), Regulatory Audits, Risk Assessments