Inviting applications for Production(Pilot plant/Kilo lab) - Shameerpet

Role: Chemist / Sr Chemist
Department: Production
Location: Shameerpet

About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels.

Summary of Job:

To execute the production through the various stages of manufacturing as per the plan and ensure compliance to quality, safety & regulatory requirements.

Key Responsibilities:

·         Review the Batch Production Records.

·         Preparation of validation protocols and its reports.

·         Preparation of monthly reports

·         Ensuring that the production facilities are clean and hygienic.

·         Handling of Deviations followed by preparation of investigation reports by discussing with cross-functional team and closure for deviations in GMP Pro. 

·         Initiation and closure of planned change, change controls, initiation of procedure and CAPA manufacturing of intermediates and API’s. 

·         Handling of Risk assessments and impact assessments for respective changes. Ensure that new appropriate, modified facilities and equipment are qualified.

·         Ensure the premises and equipment are maintained.

·         Ensure that all the production deviations are reported and evaluated, that critical deviations are investigated, and the conclusions are recorded.

·         Participating in cGMP, production, and safety-related training activities.

·         Train the concerned personnel as a department training coordinator.

·         Prepare and approve the (If required) protocols and reports.
Co-operate with the maintenance department in the execution of preventive maintenance schedules for production-related equipment and other Job orders.

·         Coordinate with all CFT departments.

Experience/Qualification:

·         M.Sc/ B.Sc/ Diploma (Chemistry/Chemical) with 2-8 years of relevant Pilot plant/Kilo lab experience.

Key Competencies (Technical, Functional & Behavioural):

·         Basic knowledge of API process and handling production machinery of manufacturing.

·         Good interpersonal Skills