General Manager - Quality Assurance - Pharmaceutical API

Position Summary

GM - Quality Assurance (QA) is responsible for leading the quality assurance functions within the organization. This position has the overall responsibility to oversee the maintenance of product quality and compliance through the Quality Assurance function as well as management of the Quality Management System and compliance processes.

- The incumbent will provide strategic leadership and coordination of these key functions to ensure that the short-term and long-term objectives of the company are met

Job Interactions & Interface

- Internally this position interacts with all departments within the organization and with management and employees India. Externally this position interacts with government authorities, industry organizations, consultants, vendors, legal counsel and health care professionals.

Job Requirements

- Manage the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures (SOPs) as required.

- Ensure compliance (GMP, GXP) with appropriate SOP's in-line with practice & various Health Regulatory Authorities and guidelines.

- Liaise with peers in other operating companies to share experience and best practices

- Support and lead QA Specialist/ qualified person for internal quality compliance matters

- Support and lead the QA Specialist to liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.

- Support and lead the Compliance Specialist for QMS and other compliance programs

- Coordinating new launch shipments

- Handling of product complaints

- Ensuring inspections of distributors and wholesalers as necessary per GMP requirements

- Acting as primary quality contact person with Third Party Logistics (3PL) and as qualified person for internal quality compliance matters

- Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals

Additional

- Provides work direction plus has responsibility for hiring, promotions, transfers, performance management, discipline and termination

- Identify resource and skill gaps and recruit staff as required and effectively outsource projects as needed

- Lead an experienced team of professionals and provides training on policies and procedures, and regulations and guidelines, both existing and emerging

- Execute other duties as may be required by the Management Team and other members of Leadership Team as training and experience allow.

Qualification & Experience

- M.Sc. M.Pharm, P.hD. in Pharmacy from a reputed college with 12-15 years of experience in API or Bulk drug industry