Associate Manager - QA Review (CQ)

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