How you’ll spend your day
To prepare review, approve and distribution the instruction for the production of intermediates and /or APIs according to written procedure.
To Ensure that all production deviation are reported and evaluated on time, critical deviation are investigated and the conclusion are recorded as per the standard 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;
Leads, staffs, and develops a motivated, skilled and optimally resourced team to ensure that performance levels and professional development achieve or exceed business objectives;
Act as qualified trainer of those with less experience. Conduct in-direct supervision of others in the team
Provides input into annual performance evaluations of production technicians as applicable. Investigate and resolve problems. Clear and concise communication to Process Lead and Supervision
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.
As an Opex champion, identification of improvements projects in respective area and supporting functional head to implement the project
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.
Knowledge of execution of new modification project and implementation timely.
Knowledge about operation and handling of liquid chromatography and rotary evaporation
Your experience and qualifications
B.Tech / B.E (Chemical) with 10+ years
