Quality Assurance-Validation

Role & responsibilities

Preparation of Standard operating procedure (SOP) and also prepare planner for qualification as and when required.

Review of documents like, Standard operating procedure (SOP), Validation and qualification protocol and report ,planner for qualification/calibration/preventive maintenance, validation sampling plan, Stability protocol, Master Batch records (MFR,BMR,BPR) executed Batch records, Investigation report, change control, deviations, discrepancies, laboratory events, CAPAs, OOSs, Market complaints and product recall.

Participate in process validations and cleaning validation, Media fill, management review of process performance, Stability management.

Monitor all aspects of manufacturing, processing, packaging and stop operations, if required to ensure compliance with established procedures and cGMP norms..

To ensure that training of self is completed on time.

Issue, initiate and evaluate QMS documents. Investigate the failures, investigate and determine the disposition of returned good ,approved or reject change control, deviation, discrepancies, laboratory events, CAPAs, OOSs, and OOTs, Market complaint and product recall.

Maintain reserve sample/control sample of raw material /finished product as per the specified storage condition.

Issuance, control, retrieval, retention and destruction of documents like specification, SOPs and their formats, test data sheets, validation protocol and their formats, logbooks, qualification formats, batch manufacturing records, batch packaging record and FP reports etc.

To ensure compliance to safety, quality, ethical conduct, and data integrity policy and to escalate any potential risk or suspected DI violation to the management as per ECDI policy.

Investigate market complaint, maintain investigation records and initiate product recall whenever applicable.

Conduct audit program and compliance to audit/inspection obsevations and prepare the annual product quality review for trend analysis.

Ensuring that a timely and effective communication and escalation process exists to raise quality issues to QA head /Designee.