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.

- Solid 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.

Job Snapshot

Updated Date

14-09-2026

Job ID

JOB10072

Division

MORAIYA QA

Location

Manufacturing-formulation|for.mfg.moraiya, Ahmedabad, Gujarat, India ..+ 1

Experience

3 - 5 Years

Employee Type

P-P7-Probationer-HO Staff

📌 Quality Assurance - IPQA (Moraiya) (India)
🏢 Zydus Group
📍 India