- Experience of preparation of Technology Transfer Documents (TTD), QMS, Compliance, SOPs.
- Preparation of documents for OSD (tablets/capsules/pellets) for regulatory markets.
- Audit preparations
- ANDA submission related documentation
- SAP transactions
- Preparation of Technology Transfer documents (TTDs) like batch records, qualification protocols, stability protocols for scale up/registration/intended commercial batches.
- Preparation and issuance of site variation/ query response documents.
- Maintain record of test licence, manufacturing licence, punch change part procurement, Master Formula Card (MFC)
- Monitoring proper transfer of documents from R&D to Plant QA
- To review and approve change control, deviations and implementation of changes to meet the compliance.
- To co-ordinate predefined frequencies calibration for IPQA instrument and equipment.
- Impart training to F&D team members on various aspects of GMP/GLP guidelines and practices.
- Co-ordinate predefined frequencies calibration for IPQA instrument and analytical equipments and its periodic review.
- Preparation of SOPs/Department manuals, Formulation department manual, its issuance and archival.
- Conduct periodic review of lab note book for the experiments carried out in labs.
- Maintenance of IQ, OQ, PQ, manuals of equipments/ instruments
- Innovator sample management
- Review the audit recommendations for compliance
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category:Drug Regulatory Affairs/Documentation
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
PG:M.Pharma - Pharmacy
Unichem Laboratories Ltd
Contact Company:Unichem Laboratories Ltd