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
