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Natural Biogenex

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3.2

based on 5 Reviews

8 Natural Biogenex Jobs

Manager - QA

Natural Biogenex Pvt Ltd

3.2

based on 5 Reviews

10-15 years

Tumakuru

1 vacancy

Manager - QA

Natural Biogenex

posted 25d ago

Job Role Insights

Key skills for the job

Pharmacy QMS Continuous Improvement Quality Audit Manufacturing Process Supplier Audit

Job Description

2 Manager-QA Qualification :-MSc.- Chemistry Experience :- 10 to 15 years in API Location :- Vasanthnarasapura KIADB Industrial Area, Tumkur Dist. , Karnataka. Job Role :- Develop and maintain a robust quality management system following current Good Manufacturing Practices (cGMP) and other applicable regulations. Implement quality assurance procedures and ensure their effectiveness. Stay updated on pharmaceutical industry regulations, guidelines, and standards. Ensure the companys compliance with regulatory agencies. Oversee the assurance of products throughout the manufacturing process. To conduct quality audits, inspections, and investigations as required. To initiate change control, CAPA, Deviation investigation, Failure investigation, Handling of OOS Results, Handling of market complaints, Vendor Assessment/Vendor Qualification. Vendor Management, and Handling of OOT. Preparation and review of Protocol, Report, and preparation of IQ, OQ, and PQ protocol and report. To perform a gap assessment, preparation of QRM, Preparation, and Review of the SOPs. Maintain accurate records of quality assurance activities, investigations, compliance, and documentation. Ensure proper documentation of product specifications, batch records issuance/review (BPR/BMR). Preparation/review of equipment qualification records, protocol reports and change control processes. Evaluate and manage the quality of raw materials, components, and suppliers in compliance with company standards. Conduct supplier audits and assessments CAPA (Corrective and Preventive Actions). Provide training to the employees on quality assurance, GxP, and cGMP principles data integrity good documentation Practices. Foster a culture of compliance, quality, and continuous improvement.. 1 Tumkur, Karnataka

Employment Type: Full Time, Permanent

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