Industry - Pharma / Biotech / Clinical Research

Category - Consulting

Skills - Quality Assurance

Job Type - Permanent

Job Description :

- 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 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 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; analysing variance etc. and initiating corrective actions, where required.

- Ensure all batches manufactured and released from the site are in compliance to 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 cost of poor quality and control / reduce 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 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.

Contact - Afrin Patel -

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