Website Zydus group ltd
Post 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.
