Zydus Hiring For Officer to Assistant Manager QA
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| Zydus Hiring For Officer to Assistant Manager QA |
Position: Officer to Assistant Manager QA
Location: Ahmedabad, Gujarat, India
Division: VTC MFG. QA
Experience range (Years): 3 years - 9 years
1.Officer/Executive with 0-2 Yrs of Experience in IPQA department (R&D - QA)
To ensure shop floor compliance for GMP, GDP, pertaining to facility/systems /equipment / documents.
To review SOP, Batch records PDR related to Phase I or Phase II batches of manufacturing and warehouse.
To provide line\equipment clearance prior to manufacturing, sampling and packaging and validation activity during Batch and Product change over.
To review SOP’s of warehouse department and verify compliance for the same.
To ensure line clearance for dispensing activity and review the data of analysis.
To Archive Master Copy Document and ensure security of the soft copy of the master document.
To issue copies of the master document (SOPs, Batch record, format logbooks, Protocol) to other department.
To retrieve the Obsolete /superseded copies of the documents distributed to different functions.
Perform the Requalification/Equipment of equipment deep freezer, liquid nitrogen system.
2. Officer/Executive with 3-5 years of experience in QA (Qualification and Validation)
Preparation & review of Installation Qualification, Operational Qualification and performance Qualification protocols and Reports of equipment & facilities.
Preparation & review of User Requirement Specification.
Review of all supplier/in house documents required for qualification of Equipment, utilities and process.
Execution & review of requalification/Periodic qualification of equipment, utilities and area.
Review of final validation/Qualification reports.
Coordinating the validation activities with cross functional team.
Compilation & review of Qualification protocols and reports in co-ordination with cross functional team.
3. Assistant Manager/Deputy Manager with 6-11 years of experience in IPQA department
Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement.
To provide line/equipment clearance prior to dispensing, manufacturing and packaging and validation activity during Batch and Product change over. Ensure shop floor compliance.
To ensure sampling as per defined frequency and methodology during batch manufacturing of all validation activities and exhibit batch manufacturing and do the entry of the samples in LIMS software.
To review executed batch manufacturing and batch packing record for accuracy, completeness and compliance. To review manufacturing log books and environmental monitoring records and to ensure contemptuous documentation.
To prepare SOP related to QA-Operation.
To collect, compile and take follow ups from cross functional department for APQR data compilation & APQR preparation. Participate in investigation of reported Microbial data deviation at DS & DP Manufacturing facility.
To participate in execution of Process validation activity, Campaign change, cleaning validation and inactivation kinetics study etc.
To review electronic records like PLC, SCADA, equipment printouts, audit trails, alarms and events as per site SOP.
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