Harman Finochem - Manager - Quality Assurance - API

QA Manager API for Aurangabad location

Experience - 10-15 Years, Preferably from API industry

Education: MSC Chemical / BE Chemical / B.Tech Chemical /M Tech Chemical / MSc Organic chemistry

- Responsible to manage GMP Compliance and implementation of effective quality management system in site, batch release of intermediates and APIs. Accountable for investigations against deviations, out of specifications, Market complaint, product recall and its CAPA effectiveness verifications as per the identified root cause.

- Review, approval and monitoring of process / analytical method validations. Accountable for handling of qualifications and preventive maintenance of equipment/instruments.

- Drive the quality improvement initiatives in site and coordinate with all cross functional teams to avoid the data integrity breaches.

- Strict adherence and compliance to cGMP as per the expectations of various regulatory authorities and safety rules of the factory.

- Review and approval of investigation reports associated with Generic, service intermediates and APIs during the manufacturing/testing operations followed by monitoring of CAPA till closure.

- Responsible for Audit readiness and handling of various audits, response & closure.

- Review and approval of APQR for APIs & Intermediates.

- Conducting the internal & external audits as per GMP/ISO9001 standards.

- To support material management by vendor evaluation and approvals.

- Handling of Market complaints & product returns/recalls and timely response to technical queries from the clients.

- Support all the QMS elements for timely review, approvals, implementation, closure & tracking of the same for the quality metrics and take the appropriate actions to improve the effectiveness.

- To review and approval of Standard Operating Procedures, Specifications and Test procedures through electronic system called ensure.

- Attending customer calls and meetings as per the schedules.

- Monitoring of quality agreements with various clients.

- To maintain effective oversight on training management and document lifecycle management.

- Ensure the quality assurance programmes and policies are maintained and updated regularly according to the requirements.

- Co-ordinate with internal & external stakeholders to meet the business requirement