Director at Ideal Consultants
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Site Quality Leader - Insulin Cartridge Project - Pharma (15-24 yrs)
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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