HR at At Stroke HR Consultancy
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Assistant Manager - Quality Assurance - Pharma (8-10 yrs)
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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