To execute the production through the various stages ofmanufacturing as per the plan and ensure compliance to quality, safety ®ulatory requirements.

Key Responsibilities :

Review the Batch Production Records.

Preparation of validation protocols and itsreports.

Preparation of monthly reports

Ensuring that the production facilities areclean and hygienic.

Handling of Deviations followed by preparationof investigation reports by discussing with cross-functional team and closurefor deviations in GMP Pro.

Initiation and closure of planned change,change controls, initiation of procedure and CAPA manufacturing ofintermediates and APIs.

Handling of Risk assessments and impactassessments for respective changes. Ensure that new appropriate, modifiedfacilities and equipment are qualified.

Ensure the premises and equipment aremaintained.

Ensure that all the production deviations arereported and evaluated, that critical deviations are investigated, and theconclusions are recorded.

Participating in cGMP, production,



andsafety-related training activities.

Train the concerned personnel as a departmenttraining coordinator.

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

Coordinate with all CFT departments.

Experience/Qualification:

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

Key Competencies (Technical, Functional &Behavioural;):

Basic knowledge of API process and handlingproduction machinery of manufacturing.

Valuable interpersonal Skills

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Production Professional (Pilot plant/Kilo Lab) (Shamirpet)
🏢 Sai Life Sciences
📍 Shamirpet