3 years 4 months (2 years 11 months) - Site Audits / Inspection / Investigation / Readiness / Improvements - GMP/ GDP / GLP / GCP (MO/CRO/CDMO/CMO) - QMS, QbD & ISO 90001, ISO 14001, ISO-17025 Development / Execution / Implementation - GxP Vendor Audits & Trainings - Risk Management & Change Control - Mock Regulatory Inspections / Audits - GAP Assessment / Analysis / Development (GxP / GMP / GLP / GDP -SOPs) - Trainings (GMP / GLP / GCP / GxP / CAPA / RCA / OOS / OOT / HSE, etc.) - R&D and Quality Testing Labs Development & Qualification

(3 years 4 months)

(3 years 8 months)

(2 years 6 months) • Manage the Site Analytical Services & Analytical Science & Technology (AS&T) activities to ensure the compliance of analytical methods and associated Quality Systems as per requirements of the company’s manual and all regulatory and legislative requirements across the lifecycle of the OTC products. • Support analytical activities at third parties • Establish and maintain Quality system for the Analytical Services group; ensure that Standard Operating Procedures are in place and that compliance with cGMP is maintained through on-going training and internal audits • Ensure the implementation and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) • Ensure that all new product launches and commercial BD&L projects are adequately supported through Analytical Services activities in line with company Quality Manual requirements. • Ensure that the Analytical Services group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practice.

(3 years 3 months)