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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Supports pharmaceutical manufacturing compliance through document management, electronic form conversion, audit response preparation, change control coordination, CAPA and CCF tracking, manufacturing walkthroughs, and process improvement. The role collaborates with cross-functional teams to ensure documentation readiness and timely inspection preparation while maintaining compliance with cGMP requirements.
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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Leads quality oversight for sterile injectable manufacturing, ensuring cGMP compliance, regulatory readiness, documentation accuracy, batch record review, SOP approval, investigations, CAPA effectiveness, audits, and continuous improvement. Manages quality personnel, partners with production operations to resolve compliance issues, and supports inspection and corporate quality standards.
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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Manages enterprise operational excellence and continuous improvement programs across Pfizer. Leads Lean Six Sigma projects, develops performance metrics, oversees governance and resource planning, coaches project teams, facilitates cross-functional collaboration, and implements IMEx initiatives. Maintains procedural documentation for clinical, medical, safety, and regulatory processes, supports audit readiness, delivers Yellow Belt training, and applies statistical analysis, change management, and problem-solving methods to improve operational performance.
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Change ManagementImex (Integrated Manufacturing Excellence)Lean ManufacturingLean Six SigmaStatistical Analysis
Lead and review analytical method validation, transfer, and verification activities for sterile dosage products. Oversee QC testing (HPLC, GC, IC, ICP‑MS, etc.), equipment qualification, change control, risk assessments, stability management, and regulatory/GMP compliance. Prepare and review technical documentation, support inspections, and collaborate cross-functionally to ensure data integrity and method suitability for new product introductions.
Experience: Master's degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation executions in Quality control Laboratory and Quality Review of sterile dosage manufacturing facility.
Core Competencies
Technical Skills
Behavioral/Any Other Skills
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Core Competencies
- Analytical Method Validation/Transfers/Verification
- Change Management process
- Risk assessments principles and tools
- Qualification of lab equipment's
- Regulatory requirements & Compendial Changes
- Stability Management
Technical Skills
- Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniques
- Qualified in multiple analytical techniques(HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, AAS, XRF, NIR and pH meters)
- Demonstrated technical skills in method validation and testing
- Having Capability to understand the Compendial methods and Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards.
- Interpretation of analytical systems generates data against the procedure requirements.
- Having capability to assess the test method requirements against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
- Review of document analytical method verification and method transfer activities.
- Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
- Perform identification, assay, purity, and related analytical tests using validated methods.
- Having Knowledge on assessment of Elemental Impurities, Nitrosamine impurities, Extractable & Leachable and its guideline requirements.
- Knowledge in validation principles and practices related to the Process validation, cleaning validation, Analytical Method validation, Water system, HVAC system, Equipment & Utility Qualifications.
- Knowledge of various Quality tools required for investigations
- Technical Writing- Ability to create documentation that is accurate, complete, unambiguous, and as concise as possible aimed to be understood by any level of organization
- Knowledge in change control assessment
- Basic idea on manufacturing operations, validation and engineering functions
- Experience in handling Regulatory agency inspections
Behavioral/Any Other Skills
- Interpersonal Skills: Effective communication with all colleagues from different levels and builds constructive and effective relationship
- Managerial Skills: Persistent approach to resolving issues, Effective situation handling capabilities, strong time management skills.
- Acts Decisively: Makes decision in a timely manner based on available information
- Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
- Self-accountable & Proactive approach
- Strong scientific and analytical thinking
- Excellent review and documentation skills
- Regulatory and GMP compliance mindset
- Investigation and problem-solving capabilities
- Cross-functional collaboration
- Leadership and mentoring skills
- Attention to detail and data integrity focus
- Effective communication and stakeholder management
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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
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