Associate Manager - QA Review (CQ)
About the role
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
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
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Quality Assurance and Control
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