• Be responsible to lead down stream manufacturing compliance.
• Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements
• Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item.
• Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA.
• Responsible for the review and approval of Master manufacturing records for the commercial batches.
• Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records.
• To review and approve the quality risk assessment for the equipment and process.
• Responsible for compliance to audit observation, tracking and implementation of audit commitment action items
• Monitoring training metrics on daily basis for all the production employees with on time training without past dues.
• Continue to ensure stock availability of all consumable material for production.
• Responsible for review of compendial assessments.
• Responsible for the review and approval of trends and APQR.
• Responsible for the review of SQRT slides for the trends.
• Coordinate with QA documentation and production for issuance and retrieval of document to and from production.
• Support site inspection readiness program in providing updating on commitment tracking action items to Production leadership team and QA.
• Perform regulatory observation network assessments gap assessment for manufacturing process and system at Vizag site and implement identified gaps.
• Review and approval of documents in PDOCS
• Coordination and monitor training metrics for timely completion of production colleagues and contingent worker training.
• Implement cGMP and ensure compliance of SOPs, Quality Systems, Safety Systems and Pfizer policies at all stages of activity
• Participate in regulatory, corporate and internal inspections
• Support in development of responses to market complaints and implement corrective actions
• Support investigation, identify root causes and suggest CAPA
• Review and approval of change control
• Review, approval and finalization of deviations
• Recognizes development needs and identifies/creates development opportunities (e. g. , special assignments) for colleagues within own functional area
• Develops a talent base and anticipates development needs within the area of responsibility
• Manages performance of direct and indirect reports and support functions / area objectives through goal setting, ongoing assessment and coaching and performance evaluation.
• Engage and inspire the team on performance expectations and coach the team to meet those expectations using Coaching Skill principles

Here Is What You Need (Minimum Requirements)

• Postgraduate in Science / Pharmacy with 6+ years of experience or Degree in Pharmacy with 8+ years of experience in Quality and Compliance role in a sterile pharmaceutical manufacturing unit
• Experience in preparing for and facilitating regulatory inspections by agencies such as the FDA and EMA
• Demonstrated ability to manage multiple projects and ongoing work activities
• Strong problem-solving skills and ability to troubleshoot during unexpected events
• Proficiency in Microsoft Office tools
• Strong written and verbal communication skills
• Robust customer service mindset

Bonus Points If You Have (Preferred Requirements)

• Experience in People Management and supervisory roles
• A deep understanding of Quality Systems within the pharmaceutical industry
• Excellent negotiation and influencing skills
• Ability to foster a culture of inclusion and knowledge sharing
• Proven track record in developing and leading senior-level resources
• Strategic thinking and ability to act as a strategic advisor on key Enterprise initiatives
• Experience in managing and driving compliance initiatives to ensure inspection readiness

Role: Risk Management & Compliance - Other