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HR at At Stroke HR Consultancy

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Assistant Manager - Quality Assurance - Pharma (8-10 yrs)

Aurangabad/Maharashtra Job Code: 22982

JD for Asst. Manager-QA

Qualification : M.Sc.-Chemistry

Experience : Female Candidate with 8-10 years of experience from API Industry

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

- Timely reply to customer queries.

- To monitor and prepare budgetary provisions for procuring new QA equipment, upgrade the facility and smooth working of the department.

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

- 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, Handling and Managing of audits to meet AMRI ILS requirement.

- Performing on site audits of vendors as per the requirements given by other AMRI global sites.

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

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

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

- To review and approve 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 and approve 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 and approve 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 and approve 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 and approve Certificate of Analysis as per the customer requirement.

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

- To Review and approve Vendor Qualification documents.

- PR requisition in oracle.

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

- Responsible for Environment, Health and Safety Compliance.

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