Quality Assurance Manager - Export

Pharma Jobs India
  • Pune
  • Confidential
  • 8-13 years
  • 01 Sep 2015

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research, Bio - Tech
Job Description

  • Preparation & review of batch documents, protocols include Specifications, BMR, BPR, Transfer protocol, Scale up protocol and Report, Process Validation Protocol & Report etc.
  • Timely support for Initiation, follow up and closure of quality compliance documents like Change Control, Deviation, OOS and Investigation Reports for betterment of Product Quality.
  • To review all the documentation related to regulatory submission and submit to regulatory department. Ensure cGMP and respective regulatory requirements before final submission to RA.
  • Maintains the document management system to ensure required documentation and data are on-site for internal and external team.
  • Assist regulatory team for regulatory Deficiencies & Query responses.
  • Collection of vendor evaluation documents for R&D and CMO partners.
  • External Audit for API suppliers. To provide audit compliance to external audit observations and follow up to meet the compliances date.
  • Conduct external audits at CROs and analytical labs, as required.
  • Review for technical, quality and GMP agreement w.r.t. quality aspects.
  • Coordinating the investigation of customer complaints.
  • Support for the preparation of Annual Product Review.
  • Analytical and QC experience will have extra weight age.
  • Efficient inter and intra departmental and across the sites communications.
  • Provide weekly and monthly reports to senior managers on performance
  • Awareness of regulatory requirement and customer service expectations.
  • M.Pharm / B.Pharm graduates with 8+ years experience in QA/QC functions with US-FDA, MHRA, TGA approved pharmaceutical companies. Must be at Manager level or eqv at present.
  • Should be a resident of Pune or those who are willing to relocate to Pune on long term basis.

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