General Manager - Quality Control - Pharmaceutical API

Position Summary

GM - Quality Control (QC) is responsible for leading the quality control functions within the organization. This position has the overall responsibility to oversee the operations of Quality Control lab for Raw materials, Packing Materials, Finished products and stability analysis with high standards of quality and in adherence to all quality systems and processes.

Job Interactions & Interface

Internally this position interacts with all departments within the organization and with management and employees India. Externally this position interacts with governing authorities, industry organizations, consultants & vendors.

Job Requirements

- Provides leadership and direction to a team of 25+ Quality control professionals; grows and develops the team to meet evolving business needs; is accountable for Quality Control.

- Ensures that a robust cGMP training program is developed and administered

- Ensures that all products compounded at the site are produced, tested, and released in compliance with SOPs, cGMP- s, FDA and DEA requirements.

- Improves, develops, establishes and drives contemporary Quality Systems and processes

- Leads a Quality metrics program to enable a strong Management Review

- Collaborate and facilitates interactions between Quality, Pharmacy and Operations teams to meet customer requirements and timelines, while maintaining compliance.

- Ensures that systems, resources, and action plans are consistently reviewed and decisions made to enable sustainable compliance.

- Manages customer complaints, makes batch rejection decisions and manages recall decisions in conjunction with the quality operations head

- Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols

- Directs continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness and enhanced efficiencies of processes and procedures pertaining to Quality.

- Prompt communication to Site Head / Management any other management of critical cGMP and/or non-compliance issues.

- Acts as a member of the site leadership team and engages in business decision-making from a Quality perspective.

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 quality policies and procedures, and regulations and guidelines, both existing and emerging

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

Qualification & Experience

- M.Sc. M. Pharm, P.hD. in chemistry, microbiology from a reputed college, with about 12-15 years of experience in reputed API/Bulk drug manufacturing organisation.