Executive Regulatory Affairs

5 days ago

Malad Mumbai Maharashtra, India Turtle Pharma Private Limited Full time

**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.

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

Schedule:

- Day shift

**Experience**:

- total work: 10 years (required)

Work Location: In person

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