Quality Assurance Manager

2 months ago

Kozhikode, India Jay FineChem Private Limited Full time

Manager / Senior Manager (Quality Assurance).

  • Candidate Preferably working with API/Intermediates manufacturing plant with min 5 years of experience as HOD
  • Responsible for conducting audits in plant, to implement cGMP system,
  • To train QA personnels, monitoring of QA functions,
  • To ensure that API/intermediate products manufactured by the company meets the quality standards,
  • Responsible for preparation, approval and compliances of following documents and records
  1. Site Master file
  2. Validation master plan
  3. Standard Operating Procedures.
  4. Equipment Qualifications
  5. Protocols (Process Validation, Equipment Validation and stability).
  6. Annual Product Review.
  7. Vendor Approval (RM and PM)
  • Review Out of specifications (OOS), Out of trend (OOT), Out of Calibrations (OOC) and Laboratory Incident investigations and guide the team in handling such situations in scientific manner which includes thorough investigations and appropriate CAPA.
  • Handle various quality management systems like change controls, deviations, quality risk assessments pertaining to quality control laboratory.
  • Understand and perform analytical method validations, analytical method verifications and analytical method transfers as per various regulatory requirements.
  • Conduct training on various aspects of quality control operations and its compliance, computerized system validations.
  • Perform qualification of various analytical instruments in the laboratory.
  • Review of data backup and restoration.
  • Review of elemental impurity risk assessment and Nitrosamine impurity risk assessment.
  • Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
  • Organize and execute internal audits at all plants and corporate departments as per the annual planner.
  • Ensure compliance with cGMP, cGLP requirements and good documentation practices.


  • Qualifications

10- 15 years in API industry

B. Pharm/ M. Pharm/ M. Sc (Organic/ Analytical

Chemistry)

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