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Senior Executive / Assistant Manager-Quality Assurance


Crimsun


Location

Cuddalore | India


Job description

Will be heading our Quality assurance dept, shall be responsible for implementation of Quality Management systems, like reviewing / approving of SOPs, creation / Implementation of SOP related to QA assurance dept, review, approval and issue, control of BMRs.

Review of batch quality and BMR compliances.

Approval and release of batches.

Review & approval of investigations on batch deviations, out of specification (OOS) Batches, ensuring the effective implementation of CAPA.

Review and approval of RM quality data, vendor audits, vendor approvals, new RM approval, safe custody of documents as per regulatory requirements.

Ensuring operating/maintenance people trained on the relevant manufacturing activities.

Co-ordination of audit by customers, regulatory agencies. Ensuring all the regulatory retirements are met 100 %, and all the audit commitments are effectively implemented in time. Preventing recurrences of deviations and OOS etc.

Knowledge about implementing the Quality, Environmental and Safety management systems (ISO 9000,14000, OHSAS18000).

Educational & Training Requirements:

Knowledge, Experience and Skills:

* 7-8 years experience in Quality Assurance profile in the Pharmaceutical, Pesticide, Chemical industries.

* Good team working person, with effective written and oral communication skills, also should be good at emotional intelligence.

* Should be good at English, good fluency in Tamil / Hindi would be an added advantage.


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