Head of Quality Assurance - Indore, India - Glenmark Pharmaceuticals

Description

Implementation of QA systems and ensure its compliance. Qualifications, Validations Compliance. To impart training. Authorization of Market Complaint investigations.

1) Implementation of QA systems and ensure its compliance. Authorisation and implementation of all quality management documents such as change controls, deviations, incidents, market complaints, APQR, validation, qualification, stability, OOS, OOT, CAPA, risk assessments, etc. Oversee shop floor activities with respect to IPQA. Evaluation and authorisation of repacking and salvaging of the batch. To overview manufacturing operation of OSD, SSD formulations, equipment operations as a part of QMS investigations.

2) Self-inspection and compliances at site. Impart training per the annual training calendar and perform evaluation.

3) Authorisation of market complaint investigations. Provide support to production and R&D for technology transfer for new products executed on site. Approval and control of all master and executed documents. Ensure the Good Documentation Practices for all executed documents. Approval of monthly report and submission to CQA.

4) Compliance of internal and external audits conducted with respect to GMP controls. Provide support to CQA for vendor audits and approval of raw material and packing material vendors. Inspections and approvals of contract laboratory/service provider. Authorisation of service contracts and technical agreements.

5) Authorisation and approval of SAP activities. Release of finished product batches and follow Good Distribution Practices (GDP) requirements.

6) Evaluation and approval of Risk Assessments for various systems. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

7) To review In-process, cleaning, raw material, packing material, finished product and stability specifications.

8) To perform GMP activities like initiation, review and Approval of QMS documents (example: Change control, Incident, Deviation) in SAP system.

9) To ensure the timely launch of new product in relevant markets by effective Co-ordinate with R&D, RA and QA for submission of regulatory dossiers.

10) Ensure Good Documentation Practices for all executed documents and the compliance to principles of Data Integrity.

11) To overview Product Development, QC lab operations, evaluation of CPPs & CQAs and evaluation of in-process, finished product and stability samples as a part of QMS investigations

12) Review and participation in Quality Management Review (QMR) report of process performance, product quality, QMS and advocating continuous improvement.

KEY RELATIONSHIPS/STAKEHOLDERS

External:

Vendors, Auditors

Internal (other than Direct Reports):

Site Head, Production Head, QC Head and section Heads, Block Heads, Engineering Head, HR Head, Regulatory Affairs.

DESIRED EXPERIENCE AND KNOWLEDGE

Educational Qualifications:

B. Pharma/ M. Pharma/ M.Sc.

Experience:

Handling of Quality Systems (Change control/ Deviation/ Incidents/ Market Complaint/OOS/OOT). QA functions at shop floor. Validations. Experience of 18-20 years required.

Knowledge and Skills (Functional / Technical):

Sound Technical knowledge with respect to Products, Compliance, Training, Regulatory Audits and its readiness, Market Complaints and its response, QMS etc.

Behavioural Attributes

Team Work, Communication Skills, decision making.