Zentiva QA Officer Job Opening – Apply Online Now
Officer – Quality Assurance (Pharmaceuticals)
Locations: India / Ankleshwar
Time Type: Full time
Posted on: Posted 2 Days Ago
Job Requisition ID: R2467004
KEY ACCOUNTABILITIES
Quality Management/Continuous Improvement
- Investigation of Deviations
- Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc.
- Review the Annual Product Quality Review
- Batch Reworking/Reprocessing/Reincorporation (Coordination from QA point of view)
- Review of Master Batch Manufacturing & Packing Records
- Coordination of cGMP training activity including training of the people
- Handling of change control system
- Document control
- Assisting in complaint investigations at site
- Release/ rejection of semi-finished and finished products
- Handling of self-inspections
Compliance
- Ensure adherence to company Quality Standards, Local FDA, and other regulatory authorities
- Understanding the requirements
- Performing the Gap analysis to find out the gaps in the existing system
- Preparing a compliance plan for the closure of gaps
- Execution of compliance plans
- Review of completion for compliance activity
- Review of the regulatory dossiers, as and when required
Validations & Qualifications
- Preparation & review of Validation Master Plan
- Ensure validated status of all equipment manufacturing processes, and cleaning processes
- Review of validation plans for facility/utilities/equipment/instrument/process/computer/cleaning
- Review of protocols for qualification and validation of facility/equipment/product/process
- Review and certification of validation reports after execution of validation of facility/equipment/product/process
Documentation Control
- Preparation of quality system SOPs
- Controlled distribution and archival of documents & records
- Control of master documents
- Management of archival room
- Issuance of batch records, ATR, logbooks, and controlled formats
Assuring Quality of Products by
- Ensuring SOP compliance
- Controlling the changes made to facility/equipment/product/process and master documents by following change control procedure
- Review of Executed Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
- Review of batch records & analytical testing records
cGMP Training
- To develop training modules and organize training in GMP
- Develop and execute the overall training program in coordination with all concerned departments
QA in QC
- Review of Specifications, protocols, reports, and other GMP-related QC documents
- Review of analytical incidents
- Review of OOS investigations and reports
- Review of Audit trials for Quality control instruments
- Act as system administrator for Quality control instruments in NIR and Viscometer
Other
- Implementing the pest control program at the Pharmaceutical facility
- Review of maintenance and calibration program
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
Dimension
(e.g. Budget, number of people managed)
Not Applicable
REQUIREMENTS
Education / Experience
Education:
Graduate / Post Graduate in Pharmacy
Experience:
02-04 years in Pharma industry with awareness of Quality management systems, method validation, Qualification, Regulatory requirements
Behavioural Competencies
- (LEAD and others)
- Accountability, Authenticity, Collaboration, Courage, and Trust
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