Selvi Chiniah

Responsible to identify and improve the outcomes of operational processes with a strategic focus to improve efficiencies, reduce cost and increase customer satisfaction.

Manages and directs all activities in the Customer Complaints, internal and external auditing, quality metrics, management review, CAPA system (including investigations) and training.

Manages and directs the Quality Assurance and Quality control team.

· Quality site owner of 3 Finish Good manufacturers (GSK Parma Italy, GSK Barnard Castle UK and Cenexi Belgium) and 5 API manufacturers for the Anesthetic portfolio.

· QA representative in 2 Site Transfer Projects to Aspen manufacturing sites.

· Quality contact person for Russian Affiliate management.

· Liaise with the manufacturing sites for all quality-related items/issues such as deviations, customer complaints and distribution complaints and coordinate with complainants, distributors/affiliates.

· Handle changes from site, assess any regulatory impact and ensure its timely implementation.

· Monitor regulatory approvals and timely implementation at manufacturing sites.

· Ensure compliance of products supplied to the market with the registered details.

· Monitor the qualification status of the suppliers by maintaining up to date relevant documentation such as GMP Certificates and Manufacturing Licenses.

· Negotiate Technical agreement with sites to define QA responsibilities.

· Collaborate with the Regulatory Team/Affiliates to confirm the registered details of the product in the market (e.g. shelf-life, storage condition, specification, etc) and communicate this information to manufacturing sites.

• Responsible of Purchasing, Store (including Bill of Material preparation) and Shipping department.
• Manage a team of 9 persons.

• Reporting to CEO.
• Manage a team of 150 persons (1 production officer, 7 team leaders/trainers and operators) & 7 production lines with various customized medical devices such as balloon catheters for interventional cardiology, radiology, gastroenterology and urology.
• Manage non conformities in production, propose corrective and implement preventive actions.

• Reporting to the CEO.
• Improvement of production workflow & implementing follow up tools in production.

• Reporting to Quality Manager.
• Responsible of the Quality Control department & team of 5 persons.
• Managed Quality Management System, non conformities, preventive actions, customer complaints, calibration activity, environment control of cleanrooms and quality control of incoming raw materials/components, Quality Control on 'Work in progress' and final products, forming part of the internal auditors team, assisting the Quality Manager during external audits.

• Reporting to Managing Director.
• Manage a team of 50 persons & 2 production lines, balloon and PTCA catheters.

• Reporting to Quality Manager.
• Manage a team of 3 persons.
• Manage quality control testing and lot release of incoming materials, work in progress and final product of one production line.

• Clerk at the Finance Section, University of Mauritius.