Manufacturing Quality Assurance Executive

Sr.Executive-QA

Qualification : B.Sc/M.Sc.-Chemistry,

Experience : Male/Female Candidate with 4-10 years of experience from API Industry

- To assist the Quality-Head in executing all GMP / GLP related activities.

- Timely reply to customer queries.

- To co-ordinate with manufacturing, Stores, Production and maintenance to document any change control requirement for any changes carried out as per Quality-Head instructions.

- To release or reject all raw materials, intermediates, packing materials, labeling materials and finished products.

- Site Master File Updation, Validation Master Plan Updation, Quality Manual Updation.

- Handling of Market Complaints, Returns /Recall, Deviations, OOS, Validation report review.

- Vendor on site audits, support and handling of audits to meet quality requirement.

- Support to Quality-Head on site audits of vendors as per the requirements.

- To review completed batch production and laboratory control records of critical process steps before release of the finished products for distribution.

- To review all specifications, STPs, SOPs, BMR, BCR, MFR.

- To review all procedures impacting the quality of raw materials, intermediates or APIs.

- To review of all validation protocols and reports.

- To ensure quality related complaints are investigated and resolved in coordination with QC, QA, and production departments.

- To handle critical quality systems like deviations, change control, CAPA, training, OOS, validations and Qualifications.

- To review annual product quality reviews.

- Involvement in investigations and closure of CAPA..

- Responsible for releasing or rejecting all API- s, Releasing or rejecting saleable intermediates.

- To appraise the management of any new regulatory requirement and to take appropriate action to implement such changes.

- To review changes that potentially impact intermediate or final product quality.

- To carryout self-inspection (internal audits) of the facility to ensure GMP systems are being adhered to.

- To coordinate with the regulatory and customers auditors for timely completion of auditing, compliance reports etc.

- To review of contract laboratories, critical starting materials vendors, intermediate or APIs contract manufacturers and Quality Agreements Management.

- To make sure that there is a stability data to support retest or expiry dates and storage conditions on final product and or intermediates where appropriate.

- To provide the all documentation support to meet the local and international regulatory requirements.

- Ensure timely dispatches of the material as per the plan and DO requirement.

- To Review Certificate of Analysis as per the customer requirement.

- Taking the GMP rounds to ensure the adherence to GMP requirement.

- To Review Vendor Qualification documents.

- Taking the GMP trainings to build awareness on the site.

Salary : Best In the industry.

• It is a Full Time Manufacturing job for candidates with 4 - 6+ years Experience.