Manager – QA (IPQA) | Hetero Drugs | Jadcherla | 10.00-17.00 L

Job Description

• Responsible for monitoring compliance with the requirements of GMP.
• Responsible for review and approval of Validation and Qualification Protocol and reports and participation in the validation of Programmers.
• Responsible for review and approval of Batch Manufacturing and Batch Packing Records.
• Responsible for evaluation of in-process controls.
• Inspection, investigation, and taking of samples in order to monitor factors that may affect product quality.
• Responsible for handling technology transfer products in coordination with PD, QC, EN, R&D, RA, and AD.
• Responsible for approval or rejection, as he sees fit, starting materials and packaging materials in consultation with Head-QC.
• Responsible for monitoring and control of the manufacturing environment and plant hygiene.
• Responsible for review of SOPs. Responsible for approval of the SOPs in the absence of QA-Head.
• Responsible for review of Qualification / Validation data and preparation of reports.
• Responsible for review and approval of master batch manufacturing records and batch packing records
• Responsible for verification of vendor documents with respect to equipment/ instruments, utility, and HVAC area.
• Responsible for approval of change request notes, and deviation with respect to equipment/instrument, Utility, HVAC / Facility area.
• Responsible for approval of Specifications, Standard Testing procedures, General Test Procedures, Worksheets, and sampling instructions.
• Responsible for review and Approval of executed exhibit batch/ Process validation batch manufacturing records.
• Responsible for review and approval in investigation and handling of market complaints/ product recalls if any.

• Responsible for review of quality Records of other departments.
• Responsible for compliance of cGMP and maintain of Quality Policy
• Responsible for conducting internal audit routine GMP inspection in the plant.
• Responsible for monitoring and control of the manufacturing environment and Plant Hygiene.
• Joint responsible with Head – Production, and Manager – QC in monitoring and control of manufacturing environment.
• Joint responsible with Head – Production, and Manager – QC in monitoring and control of GMP compliance in plant
• Joint responsible with Head – Production, and Manager – QC in monitoring and control of plant hygiene
• Joint responsible with Manager – R&D, Manager – QC assessment and conclusion of stability studies
• Responsible for compliance, adequacy, and verification of the Technology Transfer Dossier
• Responsible for the final review of data/ documents compiled after execution of the exhibit batch.
• Responsible for design and monitoring of storage conditions for materials and products.
• Responsible for ensuring all necessary testing is carried out.
• Responsible to check the maintenance of the department, premises, and equipment.
• Responsible for approval of Site Master File and Validation Master Plan.
• Responsible for approval of Technical agreements related to customers.
• Responsible for Retention of documents.
• Responsible for Handling and closure of QMS documents (Change controls, Deviations, Incidents, customer complaints, CAPA, Returned goods, OOS, OOT, Failure investigations, Product recalls, and Annual product review).
• Responsible for Finished product releases and Rejections.
• Periodic assessment of the vendors through conducting vendor audit and vendor approval

Qualification: B.Pharma