Quality Assurance - IPQA (Moraiya)

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. · Strong 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.

• Experience: 3+ years
• Seniority: Mid Level
• Education: Bachelor's degree required
• Languages: English