Key Responsibilities:
• Perform sampling, inspection, and testing of raw materials (RM).
• Prepare and maintain SOPs, Specifications, STMs, and related quality records.
• Ensure data integrity, regulatory compliance, and GLP in line with applicable international guidelines.
• Review and update STMs and specifications in accordance with current pharmacopoeial compendia.
• Support continuous improvement of QC laboratory practices and documentation.
Qualifications: M.Sc. / BS in Chemistry or Pharm-D
Experience: 4–6 years of relevant experience in Quality Control within the pharmaceutical industry.
Technical Certification: Training/certification related to ISO/IEC 17025 activities will be preferred.
Key Responsibilities:
• Execute equipment, utility, and system qualification activities as per approved protocols
• Prepare, review, and execute qualification and validation protocols and reports
• Perform IQ, OQ, and PQ activities and ensure proper documentation
• Develop and review SOPs and qualification/validation-related documents
• Coordinate with Engineering, Production, QA, and other relevant departments
• Ensure compliance with GMP and applicable regulatory requirements
• Support deviation, change control, and CAPA activities related to qualification and validation
Requirements:
• M.Sc. Chemistry / Applied Chemistry, Pharm-D, or B.E. Industrial
• 1–3 years of relevant experience in Qualification & Validation within the pharmaceutical industry
• Good knowledge of GMP and qualification/validation practices
• Hands-on understanding of IQ/OQ/PQ and validation lifecycle
• Strong documentation, analytical, and coordination skills