Senior Executive - Quality Control

Job Description

Timely release & reject of Raw material & Packing material used in manufacturing of R&D and commercial batches of Finished products.

Ensuing the compliance to GLP & GMP requirement in function of allocated section of laboratory.

Ensuring stability study of the drug product as per ICH requirement and regulatory requirement of specific countries.

To plan of analysis and Review of Stability report.

Ensuring Analytical technology transfer of drug products (all the dosage forms manufactured at site) as per the laid down procedure at site.

Review and approve the master documents like Specs/STPs, SOPs, Validation protocols etc.

Ensuring compliance to quality management system like change control management, Deviation handling, Market complaint handling, Audits, Self-Inspection, Calibrations etc.

Ensuring the timely Closure & Implementation of Corrective & Preventive Actions against any deviation, OOS/OOT, market complaint or failure in Lab etc.

Ensure method transfer & validation of pharmacopeias method to develop & validate testing method for cleaning samples

Work Experience

• 7–10 years of hands-on experience in a pharmaceutical Quality Control or Analytical Development Laboratory.
• Proven experience in timely release and rejection of Raw Materials and Packing Materials used in R&D and commercial batch manufacturing.
• Strong understanding and practical application of GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) in laboratory operations.
• Demonstrated ability to plan, execute, and review stability studies of drug products in accordance with ICH guidelines and country-specific regulatory requirements.
• Experience in analytical technology transfer of drug products across various dosage forms, ensuring compliance with site-specific procedures.
• Proficient in reviewing and approving master documents such as Specifications, STPs, SOPs, and Validation Protocols.
• Familiarity with Quality Management Systems (QMS) including:
  • Change control management
  • Deviation and OOS/OOT handling
  • Market complaint investigations
  • Internal audits and self-inspections
  • Equipment calibration and maintenance
• Ability to ensure timely closure and implementation of CAPAs related to laboratory deviations, complaints, or failures.
• Experience in method transfer and validation, including pharmacopeial method adaptation and development of cleaning validation methods.

Education

Competencies