Job Description

Department Details
Role Summary
ANALYTICAL QUALITY ASSURANCE-COMPLIENCE QA
Key Responsibilities
Review and approval of analytical data pertaining to various testing of materials (Raw materials/Intermediates/Semi Finished Goods/Finished Goods)
Review and approval of specifications, Method of analysis, Observation Data Sheets, SOPs & IOPs.
Review/approval of Method validation /verification/ qualification and method transfer activities.
Issue of, Annexures, Checklists and Logbooks.
Review and approval of inventory list / indexes and area / instrument layouts of QC.
Stability study management in LIMS and Novatek Nova LIMS where applicable.
Review and Approval of stability reports and stability summary.
Issue and reconciliation of Approved and Rejected labels.
Certificate of Analysis profile review and approval in SAP systems.
Conducting GLP rounds & internal audits/Self inspection.
Review and Approval of working standard, certified standard and impurity standard Qualifications and COAs.
Review and approval Water trends and Environment trends.
Handling of SAP software related activities for batch release.
Master data approval, handling of standards / OOX / incidents in LIMS.
Review of BMRs and PDRs for Batch release / rejection as per list corresponds to authorized persons for Batch release.
Review and Approval of Dispatch COA, Pre-shipment / Typical COA.
Review and Approval of Process, Cleaning, Study and Comparability report related to Analytical.
Handling of reserve samples in LIMS.
Handling of Internal Audits / Customer Audits /Regulatory Inspections and facilitating compliance of associated CAPA (if any).
Handling of QMS activities (OOS, OOT, Deviation, Change control, customer complaints, customer returns, Laboratory incidents, CAPA, ERRATA and Risk assessments).
SCM related activities/requirements/meetings and data preparation.
Preparation, review and approval of APQR related documents.
Evaluation /Establishment of out trend limits and issuance of notifications.
Preparation. Review and approval of impurity profile trending.
To support queries from customer, marketing and SCM functions on product quality and business requirements.
Review/ approval phase wise vendor qualification documents.
Review/ approval of area/ instrument/Application qualification /re-qualification documents.
Review/ approval of decommissioning associated documents
Review of trend summary of critical utility such as compress air, nitrogen gas & process steam
Review of various certificates provided by external agencies.
Review and approval of IUT annexures/ COAs.
Handling of warehouse discrepancies.
Monitoring of Nitrogen, Air and compressed air sampling activities.
Assist regulatory science department for product filings.
Review of preventive maintenance/calibration reports.
Oversight of QC laboratory functions.
Conduct training to relevant functions.
Review/Acknowledgement of Inter office memo related to Analytical/investigations.
Management of General service providers and contract testing laboratories.
Review and approval of computer system validations and equipment qualifications.
Coordinating with cross function team members for achieving quality requirements:
Review of internal GMP rounds report / inspection outcome and review of action plan.
Preparation Review and approval of Quality Documents and procedures.
Review of Audit trail of various scientific Applications.
Responsible for approval of access control, authorization of privileges for application software.
Educational Qualifications
Required Education Qualification: MSc.
Required Experience: 5 - 7 years

Skills Required