This role will lead both the QA & QC functions and will be a one Quality lead role for all Insulin Product operations. Therefore the candidate will require experience / knowledge from both of these functional operations.

- Also essential is extensive sterile operational experience with substantial evidence of hosting EU and/or FDA regulatory compliance audits with success.

- Ensure that regulatory submissions, submitted to regulatory authorities accurately reflect site practices and that Regulatory Compliance of the facility practices, as per with registered dossiers

- Provide effective leadership for the Quality team as a whole, both at a personal level and through the Quality Leadership Team.

- Ensure compliant and effective certification and release of product including European batch release by QPs at respective releasing sites.

- Directs adherence of all functions to Quality / GMP standards and procedures across all project stages

- Effectively contribute for Health, Safety, Environment, Resources Management, Transversal Relations & Continuous Improvement

- Should act as a role model in the area of responsibility, with Persuasion, Overall Vision, Integrity, Commitment, Confidence to speak out, Listen and do.

- Proactive in implementing best practices or new technologies when appropriate

- Site specific knowledge for Supply Chain Management

Qualifications : M Sc, M Pharma

Experience :

- Eligibility to act as a Qualified Person as per EU Directives or equivalent

- Member of appropriate professional body

- More than 15 years experience within a Quality function in the Pharmaceutical industry.

- Having worked in sterile product manufacturing, dealing with and resolving associated technical and quality challenges

- Significant hands on knowledge in hosting EU and / or FDA audit compliance regulatory inspections, within sterile operating unit

Call at 8712767236

R V Bhaskara Rao

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