Production/ Manufacturing/ Engineering
Pharmaceuticals/ Life Sciences/ Clinical Research, Bio - Tech
- 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.