Job Description

Job Role:

Shall be responsible to ensure the quality control system is in place w.r.to GLP.

Shall be responsible for Planning and allotting of day-to-day analysis works.

Shall be responsible for all instruments implementation of 21 CFR compliance (Audit trail management).

Shall be responsible for laboratory investigation of Out of Specification, Out of trend and laboratory incidents and related CAPA implementations and effectiveness verification.

Shall be responsible for Implementation of pharmacopeia updates to products and laboratory systems.

Shall be responsible for Planning and implementation of Analytical method validations & method transfers and coordination with AR&D for resolving of problems.

Shall be responsible for Monitoring of calibration management, standard management and verification of pharmacopoeia updates.

Shall be responsible for Monitoring of stability management and implementation of stability fulfilment to various region customers.

Shall be responsible for Assess training needs and coordinate for fulfilment of training to all QC personnel on Instrument handling, calibrations, audit trail management and current GMP requirements. Monitor and evaluate the outcome of training and plan for retraining as necessary.

Shall be responsible for the Approval and rejection of Raw materials, packing materials intermediates and finished products, etc.

Shall be responsible to ensure review and implementation for each analysis raw data system and review of all instrument qualifications as per cGMP requirements.

Shall be responsible to attend the customer calls & coordinate with external service engineers for instrument breakdowns.

Shall be responsible to ensure that all control samples as per product storage conditions and meet the marketing simulate pack.

Shall be responsible for analytical deficiency compliance w.to Regulatory filings.

Shall be responsible for review and implementation of department SOP's and Specification and Method of analysis.

Shall be responsible for monitoring and follow up of quality control instruments electronic data backup and retrieval.

Shall be responsible for all microbiology activities.

Shall be responsible for Audit responses to various customer audit findings.

Shall report to Head Quality.