About this role
DUTIES AND RESPONSIBILITIES:
• Coordinate and plan supplier audits in conjunction with the global supplier quality, Quality Manager, procurement team, RD&E and Internal stakeholders. • Conduct ISO9001 and ISO13485 (including any applicable specific requirements) audits for suppliers based on the plan / business urgency. • Communication with suppliers on action plan preparation/review. Follow-up to the action plans resulting from these audits. • Lead or support root cause investigation of nonconformities and develop, initiate, or implement corrective actions. • Conduct periodic review and analysis supplier actions using quality tools including, but not limited to: FMEA, DFMEA, PFMEA, DQ, IQ, OQ, PQ, control plans, process verification/validation plans, equipment qualification, PDA, Cpk, SPC, statistical process control and DMAIC. • Develop, implement, and ensure that the supplier conforms to customer, internal, regulatory/legal, and certifying organization requirements. • Manage the documentation by creating, update, and control - Responsible for activities involved in supplier quality assurance. • Prepare and provide reports, communications and/or presentations to management around the development / status of Audits. • Manage and support activities related to alternate supplier approval and product specification enhancements. • Lead and support quality activities including FMEA, SPC, Internal/External audit support, SCAR, and Corrective & Preventative Actions.
QUALIFICATIONS:
• Minimum of a bachelor degree in a related discipline (Chemical engineering /Biotech engineering /production engineering/ Pharmacy etc.) and / or master degree in Chemistry/ Quality / Purchasing / Supply Chain Management. • Lead Auditor Certification for ISO9001, ISO13485 and relevant standard. • Must have considerable experience in conducting ISO, GMP audits for regulatory and non-regulatory industry by onsite/remote mode. • Understanding of Lean, 6 sigma green belt. • 3+ years of experience in Chemical or Pharmaceutical quality assurance/supplier quality assurance. • Familiarity with RCA Tools, SAP, eQMS tools, Data analytics is a strong asset.
Other skills required:
• Excellent written and oral communication • Team player who is easy to work with • Combination of big picture understanding and vision with outstanding attention to detail • Problem solver with strong analytical skills – comfortable with both theoretical and practical issues • Able to work independently and within a team. • Strong ability to document work. • Able to prioritize tasks effectively and to communicate roadblocks promptly to management within a fast-paced environment where project / team priorities may shift. • A curious person who stays abreast of the latest techniques and technologies • High degree of discretion dealing with confidential information