Proprietor at At Stroke HR Consultancy
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Assistant Manager - Quality Assurance - API (8-10 yrs)
JD for Asst. Manager-QA
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 the requirement.
- Performing on site audits of vendors as per the requirements given by other 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.