Executive / Senior Executive - CQA ( Vendor Management)

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.