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.