Zydus recruiting for our Vaccine Technology Centre at Ahmedabad for Quality Assurance Team Lead / Section Head
Quality Assurance Jobs
Team Lead / Section Head, (Senior Manager / DGM):
Candidates should have more than years of relevant experience.
The job requires to ensure CGMP implementation & its compliance in various section of Vaccines manufacturing facilities.
To prepare and review quality assurance related standard operating procedures, to ensure line clearance prior to manufacturing and packing and validation activity during batch and product change over, to review & approve TTD, process risk assessment report, GMP documents, QMS documents, qualification, validation documents and other master documents etc.
To review artwork and approve it, to review & approve processes validation / cleaning validation protocol and report, to prepare annual product review report, product summary file, batch manufacturing record and batch release in SAP.
The job also requires cross functional department co ordination for compliance as per regulatory requirements, participation in failure investigation and ensure the CAPA implementation, co-ordination in change control deviation / incident, market complaint, product recall handling and to ensure the closer of the deviation, incidences, complaints, non-conformance (if any) at site as per the time line given in respective SOPs and recommend action plan for preventing re-occurrence of similar nature of events.
Further the key responsibilities include, to conduct internal / external audits as per QMS procedure, to face the internal / external regulatory audits and prepare compliance report and verification of audit observations.
To ensure site compliance and provide data for quality index and its compliance, to review of 005 investigations reports, suggest for manufacturing level investigation if assignable cause is not determined, to close 005 investigation report and take decision on batch disposition, to undertake risk assessment in case of change proposals, unit processes for continuous GMP enhancements and product quality improvement.
To prepare or review cold chain validation protocol and ensure its compliance till distribution channel and to provide and ensure the CGMP related trainings to personnel at site.
Application Process :
Interested candidates can send in their updated CV to Rachana.Narayan@firstname.lastname@example.org