Job description:
· Implementation of cGMP of quality management system in the organization
· Ensure GMP and regulatory compliance of all functions by coordination with the customer's representative on all quality matters
· To ensure Audit readiness and handling of customer/regulatory audits
· Authorisation of all quality related documents and implementation.
· Responsible for batch release for the dispatch to the customer
· Review of quality agreement
· To implement vendor management, contract manufacturing and testing laboratories procedure
· Review and approval of qualification and validation documents. approval of VMP for facility including equipment qualification/process validation/cleaning /analytical validation
· Responsible for controlled distribution and archiving of documents
· Authorised all SOP’s, STP’s, Specifications and master processing records etc
· Making sure that all critical deviations are investigated and resolved.
· Making sure that out of specifications (OOS) / Out of trend (OOT) are investigated and resolved
· Handling and Investigation of Market Complaints and product recall
· To conduct Self Inspection and to conduct Vendor Evaluation.
· Approving raw materials/Packing material vendor, intermediate and API contract manufacturers
· Participate in interviews, induction, training and performance evaluation of all QA leads.
· Focus on continuous QA improvements including usage of appropriate testing tools, test techniques, test automation.
· Making sure that there are stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate;
· Responsible for quality risk assessments
· Performing product quality reviews.
· Approving changes (Change Control) that potentially impact intermediate or API quality;
To communicate with Regulatory Agencies for DMF filing & Regulatory Inspection
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
