Job Description

Roles and Responsibilities :

• Qualtiy Assurance and Regulatory Affairs
• Ensure compliance with regulatory requirements, including API manufacturing, CRAMs, document review, and residential inspections.
• Develop and implement effective quality control processes to maintain high-quality products.
• Preparing and Submitting Drug Master Files to customers and to regulatory bodies
• Conduct regular audits and assessments to identify areas for improvement in pharmaceutical operations.
• Preparation and review of validation protocols, reports, apex documents, and departmental SOPs. as per cGMP guidelines / WHO/EU GMP etc.
• To ensure that product are manufactured in compliance with cGMP requirement.
• To monitor, track arrange for the equipment, utility, process, cleaning, vendor and other qualification/validation related activities.
• Monitoring of validation activities.
• Prepare and review of validation master plan.
• Reviews of executed validation document for equipments, media fill, utility, HVAC, water system.
• Review of executed BMR, Media fill.
• Prepare review of standard operating procedure related validation.
• Responsible for Inspections from regulatory agencies, consultants, service agencies etc. for factory premises.
• Ensure the final checking of the finish product before releasing the batch.
• To ensure that the product are correctly processed and checked according to define procedure.
• Co-ordination is made for the manufacturer, supply and use of the correct starting and packing materials.
• Review of validation master documents.
• To check the effectiveness and applicability of the quality assurance system as per the instruction of HOD QA.
• To prepare and review the SOP for QA department and other SOP originating from QA and to review the SOP of all departments.
• Review of the BMR / BPR Filled by the Production before final release of the product and final checking of the finished product before releasing the batch for dispatch.
• To monitor and review annual product quality review report for the product.
• To review the Qualification / Validation protocols / report for equipment qualification / process validation / cleaning validation.
• To review the calibration certificate / report.
• Approve reviewing training activities; and imparting in house training.
• To carry out all such duties that assigned by HOD QA from time to time upon requirement from management.
• Responsible to conduct on job and departmental trainings to QA Personnel.

Job Type: Full-time

Pay: ?20,000.00 - ?35,000.00 per month

Schedule:

• Day shift

Experience:

• total work: 10 years (Required)

Work Location: In person