Use Your Power for Purpose
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the customer first. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that every product we deliver meets the highest standards, and your role is crucial in maintaining this excellence.
What You Will Achieve
In this role, you will:
- Be responsible to lead downstream 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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control
