Swiss Garnier - Vendor Audit Manager

Job description:

Dimensions of this role:

This position leads the Corporate Quality function and oversee supplier management and regulatory compliance at corporate and at all units of Swiss Garniers group of companies.

Travel Requirements:

This position is based at Swiss Garnier Corporate office at Chennai and may involve business travel on need basis.

Essential Duties & Responsibilities:

Quality System:

- Represents the company regarding all matters of quality.

- Overall, in-charge for developing, implementation, maintain and continuously improve quality processes and systems at all Swiss Garnier Units.

- The quality system should include the following elements, but is not limited to:

- Auditing/qualification of manufacturers/suppliers/vendors and service providers.

Quality Technical Agreements

Supplier evaluation and Qualification:

- Responsible to coordinate centralized vendor qualification and Audit activity.

- Responsible for Vendor qualification for all materials supplied to Swiss Garnier Units.

- Responsible to get the (APIs & PPMs) vendor audit date conformation / schedule / agenda preparation, intimation, vendor document review, follow up and till the audit point closed.

- Review and Monitor the Qualification documents / credential of API, excipient and primary packing material vendors and also to complete Successful Qualification report.

- Periodic updation of Qualification documents to maintain and fulfill our requirement.

- Collaborates with SCM team and site quality on the identification and spearheads the selection process of suppliers for supply of materials to Swiss Garnier Units.

- Responsible for the compliant verification at customer end and find the root cause.

- Ensure Vendor qualification process in place and in use.

- Also ensures suppliers / service providers are qualified based on Swiss Garnier and regulatory Quality standards and guidelines.

Supplier evaluation and Qualification:

- Responsible to coordinate centralized vendor qualification and Audit activity.

- Responsible for Vendor qualification for all materials supplied to Swiss Garnier Units.

- Responsible to get the (APIs & PPMs) vendor audit date conformation / schedule / agenda preparation, intimation, vendor document review, follow up and till the audit point closed.

- Review and Monitor the Qualification documents / credential of API, excipient and primary packing material vendors and also to complete Successful Qualification report.

- Periodic updation of Qualification documents to maintain and fulfill our requirement.

- Collaborates with SCM team and site quality on the identification and spearheads the selection process of suppliers for supply of materials to Swiss Garnier Units.

- Responsible for the compliant verification at customer end and find the root cause.

- Ensure Vendor qualification process in place and in use.

- Also ensures suppliers / service providers are qualified based on Swiss Garnier and regulatory Quality standards and guidelines.

Quality management of Service providers:

- Coordinate of centralized Contract testing lab (CTL) /service provider audit scheduling, agenda preparation and sharing to CTL team.

- Responsible for review and monitoring, follow-up on the Qualification documents / credential of Contract testing lab / service provider and also to complete Successful Qualification report.

- Periodic updation of Qualification documents to maintain the Compliance.

- CAPA Follows up closure, oversees the evaluation of effectiveness of the corrective and preventive actions.

Management of Quality Technical agreements (QTAs):

- Centrally coordinate to manage all 4 units QTA with Customers.

- Also manage QTA with all materials vendors, contract testing Labs and service providers for all 4 units of Swiss Garnier group of companies.

- Overall responsible for review, monitor and revise Quality Technical Agreements between Customer, materials Vendors (RM & PM) and Contract testing labs / service providers.

Audit management:

- Responsible for preparation of audit agenda and schedule for qualification audit and periodic audit, follow-up on the response, until ensuring satisfactory response and CAPA implementation from auditee end.

- Responsible for review of qualification documents (RM/PM/service providers)

Management of Corporate Quality Audit and vendor/customer Audit:

- Responsible for planning and co-ordinate with corporate Quality audits at all units of Swiss Garnier and ensure response with appropriate CAPA received and tracked to closure.

Management of Customers Audit at S.G Units:

- Responsible for co-ordination with S.G units for inspection readiness process and supporting to unit team.

Quality risk assessment and customer complaints:

- Responsible for quality risk assessment and customer complaints to coordinate with vendor to get a supported document.

- Responsible for review of elemental risk assessment and nitrosamine risk assessment.

Standard Operating procedure:

- Responsible for preparation of vendors/suppliers/manufacturers and service providers related SOP and audit related SOP.

Training Management:

- Ensure training needs are identified, approved and oversees the training program for the Quality team members and Cross functional team implemented