Quality Assurance- Assistant Manager/ Deputy @ Sahyog Jobs

Job Description

1. REPONSIBILITES: Preparation/checking/review/approve of QA SOPs, checking and approve of other departmental SOPs. Authorise to sign all the issuance documents by QA and all authorisations signing as Site QA In-charge. Checking of MPCRs, Checking and issuance of BPCRs. Line clearance activities. Review of various executed records, review and checking of Validation Protocols & Reports. Checking and review/approval of vendor qualifications. Review of analytical test data sheet, executed BPCRs and release of batch. Review of Analytical data (ADS, ATR and CoA) along with audit trail of software and its traceability. Review of Analytical Method Validation Protocol, Report, related data and its audit trail and traceability. Control, issue, distribution, retrieval of documents and destruction of obsolete document (controlled copy), recording etc. Handling of Change Control, Deviations, CAPA and OOS activities. Handling of validations, re-validations. qualification, re-qualification & calibrations. Carryout validations in coordination with the concerned production personnel / QC personnel / Engineering personnel. Monitor the trends in the process and product quality and initiate corrective and preventive actions as and when required. Stability monitoring and trend study. Maintenance and compliance of the quality system documents. Maintaining the quality standards as mentioned in the quality policy manual. Updation of guidelines of IMS systems, WHO standards and other Local FDA regulations. Involvement in the License activities of the products. Customer check list fulfilments and responding to the queries accordingly. Conducting training programs and acting as regulatory co-ordinator for DMF submissions. Handling of Audits conducted by customers and regulatory agencies. Ensure that product quality reviews (PQR) are performed. Planning and execution of vendor/customer audits. Releasing or rejecting APIs/Intermediates/Raw Materials/Packing Materials. Making sure that quality related complaints/recalls/rejections/OOS/OOT are investigated and resolved. Making sure that critical deviations are investigated and resolved. Ensuring stability data to support retest/expiry dates. Monitoring of implementation of software. Monitoring all the despatch activities and ensuring distribution of released products as per customer requirement. Qualification: M.Sc.- organic Chemistry Total Experience: 6-8 Years Job Types: Full-time, Permanent Salary: 600,000.00 - 800,000.00 per year Benefits: Health insurance Provident Fund Work Location: In person Speak with the employer +91 hidden_mobile

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: Purchase
Functional Area: Not Applicable
Role/Responsibilies: Quality Assurance- Assistant Manager/ Deputy

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Keyskills:   Change Control Deviation Management CAPA Quality Standards Training Programs APIs Intermediates Raw Materials QA SOPs MPCRs BPCRs Validation Protocols Reports Vendor Qualifications Analytical Test Data Sheet Analytical Method Validation Protocol OOS Activities Validations Revalidations Qualifications Calibrations Stability Monitoring Quality System Documents IMS Systems WHO Standards Local FDA Regulations License Activities Customer Check List Fulfilments Regulatory Coordinator Audits Product Quality Reviews VendorCustomer Audits Packing Materials Complaints Handling Recalls Handling Rejections Handling OOT Investigations Stability Data Analysis Software Implementation Mo