Description

Train and coach site leadership teams and other stakeholders with focus on the site leader, quality leader and OPEX leader. Leverage prioritized projects to deliver improved business performance & increasing skills of site resources. Improve key site processes including operations, quality, planning and other support functions to enable end to end flow. Manage and leverage external coaches to accelerate people development of site resources Partner with other OPEX Director and team members to ensure standardization. Apply change management methods to ensure effective execution of OPEX and to promote a culture and mindset of operational excellence and continuous improvement across operations with increasing external focus and embedding it into our daily work. Responsible for driving OE initiatives at block level. Coordinate with block in-charges for implementation of all OE initiatives. Key Skills: Good knowledge in QMS (Quality Management Systems) with an exposure to Regulatory Audits such as USFDA, MHRA etc. Good experience of GMP, ICH, FDA regulatory requirements, handling customer questionnaires, customer quality agreements and secrecy agreements etc. Must be Six Sigma Black Belt Certified and Lean Black belt trained. Candidate should have successful track record in implementing Continuous Improvement tools and methodologies such as Six Sigma (DMAIC), Lean, VSM, Kaizen, TQM, TPM, Kanban /5-S/Visual Workplace, Poke Yoke etc IN API Pharmaceutical Industry. Strong aptitude with MS Office knowledge MS Excel & PowerPoint, Quality, Operational Excellence and Six Sigma.

Role and Responsibilities

• Train and coach site leadership teams and other stakeholders with focus on the site leader, quality leader and OPEX leader. Leverage prioritized projects to deliver improved business performance & increasing skills of site resources. Improve key site processes including operations, quality, planning and other support functions to enable end to end flow. Manage and leverage external coaches to accelerate people development of site resources Partner with other OPEX Director and team members to ensure standardization. Apply change management methods to ensure effective execution of OPEX and to promote a culture and mindset of operational excellence and continuous improvement across operations with increasing external focus and embedding it into our daily work. Responsible for driving OE initiatives at block level. Coordinate with block in-charges for implementation of all OE initiatives. Key Skills: Good knowledge in QMS (Quality Management Systems) with an exposure to Regulatory Audits such as USFDA, MHRA etc. Good experience of GMP, ICH, FDA regulatory requirements, handling customer questionnaires, customer quality agreements and secrecy agreements etc. Must be Six Sigma Black Belt Certified and Lean Black belt trained. Candidate should have successful track record in implementing Continuous Improvement tools and methodologies such as Six Sigma (DMAIC), Lean, VSM, Kaizen, TQM, TPM, Kanban /5-S/Visual Workplace, Poke Yoke etc IN API Pharmaceutical Industry. Strong aptitude with MS Office knowledge MS Excel & PowerPoint, Quality, Operational Excellence and Six Sigma.