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

·        
Division                                  
–          Moraiya

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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.