Harman Finochem - Manager - Quality Control - API

QC Manager API for Aurangabad location

Experience - 10-15 Years, Preferably from API industry

Education: MSC Chemical / BE Chemical / BTech Chemical /M Tech Chemical / MSc Organic chemistry

Job Roles and Responsibilities:

- Determining and agreeing on in-house quality procedures, standards and specifications. Inspecting and setting standards for quality on a regular basis.

- Performing Quality Control review of documents, case report forms, protocols, informed consents, policies, procedures and reports of undertaken clinical studies.

- Ensuring tests are carried out as per appropriate standard specification and verifying the correctness of results. Conducting stability studies as per the regulatory requirements.

- Responsible for reviewing implementation, tracking and archival of SOPs, their distribution, monitoring and control. Evaluating and taking corrective actions whenever required.

- Providing support in review & approval of complaint investigations received from CMOs, corrective actions, preventive actions, closing and monitoring of the same in close co-ordination with respective SPOCs or his/her delegates as a QA responsible.

- Evaluates and presents monthly CMO quality metrics for management oversight review.

Performing Internal Audit on site - specific files, master files and various others as per the local and international guidelines and regulatory requirements.

- Responsible for approving sampling instructions, specifications, test methods and other quality control procedure.

- Responsible for change control, incident, deviations and maintaining QC records, Specification and all QMS documents.

- In addition to all the points mentioned above, the candidate should have complete knowledge of operation and familiarity of various instruments including HPLC, LCMS, GC, and TOC with good documentation and timely analysis and recording of stability data

- Ensure all stability studies are performed as per schedule.

- Preparation of shift schedule and monitoring of same.

- Ensuring co-operation between all sections of QC department