Officer - QA

Responsible for handling the products manufactured in Production block.

Review and archival of MFC and batch records.

Issuance, Review of Batch Production and Control Records, Batch cleaning record, Packing and dispatch record and Approval of batch cleaning records.

Review of qualification documents (URS, DQ, IQ, OQ and PQ).

Department rounds to ensure that the quality system is being followed in all departments.

To give line clearance to the particular equipment / area.

Training coordination, conducting training on departmental SOPs.

Data compilation and Preparation of Annual product quality review.

Co-ordination for Review and Closure of Deviations, Change controls, Out of trend and Out of specification and Failure investigation.

Handling of Track wise software for QMS activities.

Review and approval of validation protocol and reports (Process, Drying, Blending, Homogeneity, Hold time and cleaning validations)

Release or rejection of Intermediates, Recovered solvents from SRU.

Initiation of hold time study, Homogeneity study and follow up for closure.

Handling of market complaints and recalls (logging, investigation and review).

Issuance of QC protocol.

Assisting regulatory affairs department by providing required documents for filing/update.

Co-ordination for ISO internal quality and customer audits.

Issuance and follow up for updation of specifications & SOP’s.

Batch allotment for dispatch activity.

Attending customer questionnaires.

Dispatch clearance, preparation of COA’s and label control.

Follow up with support functions for closure of documents.

To coordinate for the compliance of external / Customer audit reports.

Handling of Shift activity.

Preparation, review and issuance of standard operating procedures.

Co-ordination to obtain manufacturing licenses and GMP certificates.

To follow the safe practices mentioned in various SOP’s for operations.

To participate in EHS training and adherence to EHS systems.

Review of calibration & Stability data.

To participate in safety committee meeting as and when deputed.

To give EHS related suggestions for improvement of EHS system.

Preparation of Audit compliance and follow up for CAPA closure.Role & responsibilities

Preferred candidate profile

Perks and benefits