Monitoring the equipment qualification activity and maintain the document of qualification (Autoclave, Depyrogenation tunnel, Lyophilizer).
Preparation and approval of performance qualification protocol and report and execute the qualification activity as per protocol.
To involve the qualification activity (DQ, IQ, OQ, FAT.SAT and PQ) in sterile dosage form.
To perform and involve as a team member in the failure investigation of media fill.
To review and preparation of process validation protocol and cleaning validation protocol and report.
To conducting & participating in CAPA meeting and review summary reports.
To ensure the implementation of cGMP & GDP procedures.
To review master MBR & BPR and approved the same.
To carry out the internal audits, inspections and corrective action roll outs across CFT (Cross functional team).
To preparation of risk assessment for new equipment, process, system and facility.
To review the documentation of change control & verify its effectiveness.
Approval, authorization and effective implementation of various Master Documents in plant like Quality Manual, SOPs, Protocols, MFRs, BMRs, BPRs etc
To ensure proper documentation control, distribution, archival and destruction system as per the requirement of Quality Management System (QMS).
To approve risk assessment, APQR/, APR, Validation, Calibration, and Qualification documents.
Employement Category:
Employement Type: Full time Industry: Pharma / Biotech Role Category: Pharmacist / Medical Representative Functional Area: Not Applicable Role/Responsibilies: Qa Manager
hiring in limited pharmaceuticals company in Baddi location. the qc department Hplc if anyone interstd plz send the cv on this id placement pharma2014@gmail.com