Role name: QA SME (Chemist) [ IPQA, for OSD Plant ]

· Division - Moraiya

· Department - Quality Assurance

· Category - Staff

· Qualification - B.Pharma/M.Pharma

· Experience - 3 - 5 Years

Eligibility - Minimum of 2 years in the same role at any formulation manufacturing site of Zydus in India. (minimum 2 performance rating in the current role)

Job Responsibilities:

· Monitor the manufacturing processes to ensure that the drug product is manufactured as per procedure mentioned in respective Batch Record and SOP with proper documentation.

· Ensure proper documentation practices, including accurate and complete recordkeeping.

· To conduct/ensure the periodic facility inspection, internal audits at site and to ensure compliance of observations.

· Review analytical methods, Manufacturing protocols, BMR, BPR and validation reports for compliance with regulatory standards.

· Responsible for Validation activities.

· Preparation/Review of Equipment/Utilities/Facility qualification, re-qualification documents.

· Review of analytical & Manufacturing documents including audit trails/electronic data related to Raw material, Packing material, In process, finished product, stability, cleaning, water and micro.

· To log change control, deviation, incident, OOS, OOT in TrackWise or applicable system according to SOP.

· To Evaluate proposed changes and assessing their impact and risks on safety, purity, efficacy, and product quality, cGMP system, documentation, regulatory compliance, and training requirements.





· Identify/ assign adequate action items while performing impact assessment of proposed changes.

· Identifying and involving relevant departments for evaluation and information regarding the change, such as regulatory affairs, GDSO, F&D;/R&D;, PTC, ADL, marketing, CQA, and others as applicable.

· To review post-implementation data to assess the effectiveness of changes and ensuring the closure of change controls after verifying completion of identified actions.

· To review the adequacy, quality, and completeness of all other QMS documents and investigations.

· To review investigation reports, CAPAs, and their effectiveness, and ensuring contemporaneous documentation.

· To evaluate the adequacy of derived root causes with scientific rationale and justification.

· Prepare SOPs, applicable protocols and documents.

· Responsible for issuance, distribution, retrieval, storage and control of various control documents and records like, but not limited to BMR/BPR, SOPs, specifications, STPs, logbooks, protocols etc. as per defined procedures.

· Participating in TRM (Total Risk Management) activities, identifying risks, and escalating them to the department head and governance body.





· To prepare Annual Product Quality Review & continuous verification report with action plan and CAPA, as applicable.

· To escalate the issues related to the Process, Product, Quality, Cleaning or documentation related activities to immediate superior and take appropriate action related to it.

· To escalate any failures and overdue activity that can have a potential impact on product quality to immediate reporting authority.

· Ensure Current Good Manufacturing Practices (cGMP) are followed in the facility.

· Report accidents and unsafe conditions or unusual circumstances to reporting manager.

· Other duties, which may be assigned from time to time, by reporting manager.

· Oversight in manufacturing and packing area.

· Line clearance in manufacturing & packing area

· Finished products and other Sample collection

· To perform AQL and ensure qualification of other visual inspectors

Essential job requirements:

· Understands the purpose and function of the respective area, equipment, process/operations and system.

· Proper Communication and Co-ordination with Subordinates and other departments.

· Knowledge of statistical data analysis techniques and their application.

· Robust attention to detail and ability to identify discrepancies, deviations, and non-conformances.

· Proactive approach to problem-solving and risk management.

· Comply with the Privilege rights matrix (PRM) of the Organization.

Ready to work in all shifts.

📌 Quality Assurance - IPQA (Moraiya) (India)
🏢 zydus
📍 India