Production Manager - API Facility - DPP

Job Description

Role & responsibilities •To prepare review, approve and distribution the instruction for the production of intermediates and /or APIs according to written procedure. • Ensures that all work carried out is in compliance with the required standards conforming to company e.g. cGMP, SOP, Health and Safety and Environmental requirements • Responsible for training and qualification of plant personnel and ensures that the required training is carried out and adapted according to need; • Extensive equipment knowledge to perform trouble shooting and root cause analysis. Develops solutions to complex problems requiring resourcefulness and creativity/innovation and ensures solutions are consistent with organization’s objectives. • Extensive Knowledge of Documentation in the Pharmaceutical industry related to process & cleaning validation, DHT, CHT , Cleaning Verification etc. • Extensive Knowledge to carried out investigation of any OOS/OOT/ Deviation with proper tools. • Coordination with the cross functional teams including Global teams(EHS, RA, R&D, SCM etc.) to provide accurate approach for the Implementation • Estimate base line performance and implementation of OPEX in respective area to achieve the targeted continuous improvement in cost, quality , compliances and EHS. • Extensive Knowledge about the dry powder processing Equipment and technology of Particle size distribution . • Must understand the concept of Particle Size Distribution (PSD), which refers to the relative proportions of particles of different sizes within a sample. They need to grasp how PSDs impact various properties, such as flow, reactivity, stability, and dissolution & able to identify and solve problems related to particle size and distribution.