Quality Assurance - IPQA (Moraiya)

Zydus Healthcare Limited; Ahmedabad District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Zydus Lifesciences is seeking a QA SME (Chemist) for the OSD plant to uphold quality standards within the Quality Assurance department. The role emphasizes manufacturing process monitoring, documentation, audits, and validation activities at our Ahmedabad site.

The candidate should have 3–5 years of experience in a similar role at a formulation manufacturing site, with strong understanding of cGMP and regulatory requirements, and readiness to work in shifts.

Qualifications

• Minimum of 3–5 years of experience in QA at a pharmaceutical manufacturing site.
• Experience in quality systems, cGMP, documentation practices, and change controls.
• Knowledge of regulatory standards and analytical/document review processes.

Responsibilities

• Monitor manufacturing processes to ensure drug product is produced per batch records and SOPs with proper documentation.
• Ensure proper documentation practices, including accurate and complete recordkeeping.
• Conduct/ensure periodic facility inspections and internal audits and ensure observations are closed.
• Review analytical methods, manufacturing protocols, batch records, and validation reports for regulatory compliance.
• Responsible for validation activities and preparation/review of qualification documents for equipment, utilities, and facilities.
• Log changes, deviations, incidents, OOS/OOT in TrackWise and assess impact and risk of proposed changes.
• Coordinate with regulatory affairs, QA, and other departments for change evaluation and information sharing.
• Review investigation reports, CAPAs, and ensure contemporaneous documentation and effectiveness of actions.

Job description

Job Description

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

Department - Quality Assurance

Category - Staff

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 thatthe drug product is manufactured as per procedure mentioned in respective BatchRecord and SOP with proper documentation.
• Ensure proper documentation practices,including accurate and complete recordkeeping.
• To conduct/ensure the periodic facilityinspection, 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 ofEquipment/Utilities/Facility qualification, re-qualification documents.
• Review of analytical & Manufacturingdocuments including audit trails/electronic data related to Raw material,Packing material, In process, finished product, stability, cleaning, water andmicro.
• To log change control, deviation, incident, OOS,OOT in TrackWise or applicable system according to SOP.
• To Evaluate proposed changes and assessingtheir impact and risks on safety, purity, efficacy, and product quality, cGMPsystem, documentation, regulatory compliance, and training requirements.
• Identify/ assign adequate action items whileperforming impact assessment of proposed changes.
• Identifying and involving relevantdepartments for evaluation and information regarding the change, such asregulatory affairs, GDSO, F&D/R&D, PTC, ADL, marketing, CQA, and othersas applicable.
• To review post-implementation data to assessthe effectiveness of changes and ensuring the closure of change controls afterverifying completion of identified actions.
• To review the adequacy, quality, andcompleteness of all other QMS documents and investigations.
• To review investigation reports, CAPAs, andtheir effectiveness, and ensuring contemporaneous documentation.
• To evaluate the adequacy of derived rootcauses 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, protocolsetc. as per defined procedures.
• Participating in TRM (Total Risk Management)activities, identifying risks, and escalating them to the department head andgovernance body.
• To prepare Annual Product Quality Review& continuous verification report with action plan and CAPA, as applicable.
• To expedite the issues related to theProcess, Product, Quality, Cleaning or documentation related activities to immediate superior and take appropriate action related to it.
• To accelerate any failures and overdue activitythat can have a potential impact on product quality to immediate reportingauthority.
• Ensure Current Good Manufacturing Practices(cGMP) are followed in the facility.
• Report accidents and unsafe conditions orunusual circumstances to reporting manager.
• Other duties, which may be assigned from timeto time, by reporting manager.
• Oversight in manufacturing and packing area.
• Line clearance in manufacturing & packingarea
• Finished products and other Sample collection
• To perform AQL and ensure qualification ofother visual inspectors
• Understands the purpose and function of therespective area, equipment, process/operations and system.
• Proper Communication and Co-ordination with Subordinatesand other departments.
• Knowledge of statistical data analysis techniques and theirapplication.
• Strong attention to detail and ability to identify discrepancies,deviations, and non-conformances.
• Proactive approach to problem-solving andrisk 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

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

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.