Key Roles & Responsibilities

A. Production Operations

* Execute API manufacturing activities as per approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and approved process instructions.

* Perform charging of raw materials, solvents, reagents, and intermediates as per the approved batch procedure.

* Operate reactors, centrifuges, filtration systems, dryers, condensers, and other process equipment safely and efficiently, as authorized.

* Monitor critical process parameters such as temperature, pressure, pH, stirring speed, reaction time, and vacuum.

* Carry out reaction monitoring, completion checks, and in-process sampling as per approved procedures.

* Ensure correct sequence of operations during reactions, extraction, washing, crystallization, filtration, drying, and material transfer.

* Maintain production targets while ensuring product quality, process safety, and compliance.

B. Documentation & GMP Compliance

* Record all manufacturing activities contemporaneously in BMRs, equipment logs, and relevant formats.

* Ensure entries are accurate, legible, complete, and compliant with Good Manufacturing Practices (GMP).

* Verify material names, batch numbers, quantities, and status labels before use.

* Report deviations, process abnormalities, and documentation errors promptly to the Shift In-charge or Production Officer.

* Follow approved SOPs, data integrity requirements, and applicable site procedures.

* Ensure line clearance and area clearance are completed and documented before starting operations.

C. Safety & Environmental Compliance

* Follow EHS procedures, permit-to-work requirements, and plant safety instructions.

* Wear the prescribed PPE, including safety shoes, gloves, goggles, face shields, and respiratory protection where required.

* Handle hazardous chemicals, solvents, acids, alkalis, and flammable materials according to approved safety procedures.

* Check equipment condition, earthing, ventilation, and other required safety controls before operation.

* Immediately report leaks, spills,



unsafe conditions, near misses, and incidents.

* Follow approved procedures for solvent recovery, waste segregation, effluent handling, and disposal.

* Never bypass safety interlocks or operate equipment without authorization.

D. Equipment & Housekeeping

* Inspect equipment before use and ensure it is clean, identified, and released for operation.

* Verify equipment status labels and calibration or qualification status where applicable.

* Maintain good housekeeping in the production area and ensure proper material storage.

* Coordinate equipment cleaning and cleaning-status verification as per SOPs.

* Report equipment breakdowns, abnormal noises, leaks, and instrument malfunctions to the concerned department.

E. Quality Control & Process Coordination

* Collect and submit in-process samples according to approved sampling procedures.

* Coordinate with the QC department for analytical results and process-related testing.

* Proceed to the next manufacturing step only after required approvals and acceptance criteria are met.

* Ensure intermediates and finished API materials are properly labelled, identified, and transferred.

* Prevent cross-contamination and mix-ups through proper material identification, line clearance, and segregation.

* Support investigations related to out-of-specification results, deviations, and unexpected process outcomes.

F. Shift Handover & Team Coordination

* Complete shift handover with clear information on batch status, process parameters, pending activities, and safety concerns.

* Report abnormal observations and critical process conditions to the Shift In-charge.

* Coordinate with maintenance, QC, QA, warehouse, and EHS teams as required.

* Follow instructions from authorized supervisors and support production planning.

* Train and guide junior operators on approved procedures when assigned.

Significant: The Production Chemist must prioritize personnel safety, product quality, data integrity, and GMP compliance over production targets. All duties must follow the site's approved procedures and applicable regulatory requirements.

📌 Walk-in || Chemist in Production (Males only) (Atchutapuram)
🏢 Valens Molecules
📍 Atchutapuram