Designation: Site Quality Head, PCC Digwal
Location: Digwal, Hyderabad
- Manufacturing Products in Compliance with Core values of Piramal and in Accordance with Regulatory norms/Requirements
- Ensure Process at Manufacturing site is sync with Current Regulations and of Highest Quality standards
Job Responsibility and Key Accountability:
- Lead the Quality function at PCC, Digwal site and ensure that the site meets local and international regulatory requirements and remains in compliance to cGMP at all times
- Ensure implementation of the company’s Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations at site.
- Ensure adherence to the company’s values – Knowledge, Action, Care and impact
- Overall lead and monitor all the quality activities at the site, work closely with both internal and external stakeholders
- Work across all disciplines (e.g. manufacturing, warehouse, engineering, etc.) to ensure that the site maintains a state of readiness for inspection by regulatory agencies.
- Lead the site to the successful handling of regulatory inspections and customer audits/visits.
- Develop robust CAPAs and respond to regulatory queries and deficiencies in a time-bound manner.
- Host and coordinate customer audits, prepare CAPAs and respond to the customer
- Develop and provide Quality MIS to senior management on a periodic basis. Represent site Quality at senior management review meetings
- Work closely with the Site head to achieve the site targets, without compromising on quality requirements
- Ensure that the site complies with DI requirements. All DI policies and procedures are implemented at the site and any breaches are reported and acted upon immediately.
- Achieve financial objectives by compliance to the Quality budget; scheduling expenditures; analyzing variance, etc. and initiating corrective actions, where required.
- Ensure all batches manufactured and released from the site are in compliance with Piramal and regulatory requirements
- Ensure Quality agreements are available with all suppliers, service providers, etc. providing materials or services to the site
- Coordinate with central teams for corporate initiatives, improvising, and implementing long term quality strategy.
- Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure that these changes are incorporated in the site quality systems
- Take relevant measures to avoid the cost of poor quality and control / reduce the cost of conformance.
- Receive and investigate complaints at the site and provide timely feedback and response to the customer and senior management
- Support Site head and project team for implementing new projects at the site in a timely manner
- Lead the Quality team to raise the capability levels of the team. Coach and develop the teams to take them to the next level. Work on developing a succession plan for the Quality function at the site.
- Develop training programs for the site, and ensure that only trained people perform the required job.
Educational Qualification: B.Pharma/B.Sc Organic Chemistry & Above
- Quality professional with 15+ years of experience in regulated Pharma companies with experience of both API and formulations
- Hands-on experience of quality systems in a GxP environment, and direct experience with FDA, MHRA, and other health authority inspections.
- Good knowledge of international regulatory requirements and guidelines
- Good experience of handling DI breaches and awareness of requirements
- Well-organized and detailed oriented professional, with strong verbal and written communication skills.
- Ability to lead and develop the Quality team at the site.
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