Qualifications & Validations SME - Quality - Consumer Healthcare

Our Client is global Consumer healthcare Company and is looking to expand its presence in India.

- Global responsibility to support sites, CMOs, Development Centers and Affiliates

- Guide the Q & V teams for Q & V of equipment, processes, analytical methods, cleaning procedures, computerized systems, transportation of finished products, utilities, etc. to ensure compliance to requirements of data integrity and applicable regulations.

- Review and update the Global Quality documents pertaining to processes for Q & V in alignment with the applicable emerging regulatory requirements.

- Be the SME for Q & V and support QA teams to prepare for regulatory inspections, answer any queries raised by the Inspectors and work out CAPA to close any gaps identified by the Inspectors.

- Review annual user access for Digital Quality Management Systems along with other BPOs.

- Provide training to the concerned stakeholders on topics related to Q & V and share best practices

- Leadership Stakeholder Communication, Coordination, and Reporting

- Analytical mindset with flair for automation and digitalization

- Thorough knowledge of current international regulatory guidelines pertaining to Q & V and practical experience of performing and managing Q & V of equipment, processes, analytical methods, cleaning procedures, computerized systems, transportation of finished products, utilities, etc. to ensure compliance to requirements of data integrity and applicable regulations.

- Ability to lead cross functional stake holders involved in Q & V projects through collaborative team efforts.

- Experience of facing GMP inspections by international regulatory authorities as a SME for Q & V.

- Experience of conducting training sessions and workshops on Q & V topics.