API Production Associate

About the Role

Join Avani Consulting as an API Production Associate at a reputed FMCG manufacturing company located in Nanjangud, Mysore. This position involves key responsibilities in production planning, batch execution, and GMP compliance to ensure quality and safety in API manufacturing.

Primary Responsibilities

• Plan and execute production batches according to targets while strictly adhering to cGMP and safety standards.
• Ensure all protective gear usage, gowning protocols, and entry/exit procedures are correctly followed by the team.
• Adhere to process instructions detailed in Batch Manufacturing Records and departmental guidelines.
• Maintain cleanliness and good housekeeping on the production floor.
• Ensure compliance with GMP, safety, health, and environmental regulations to deliver quality products.
• Review completed batch records thoroughly before forwarding them to Quality Assurance for final evaluation and approval or rejection.
• Promptly report any deviations or incidents and participate in investigations alongside cross-functional teams.
• Complete all document entries online with clear handwriting; correct any errors with signature and date.
• Monitor manufacturing environment conditions and maintain daily log books as required.
• Oversee preventive maintenance and calibration schedules for equipment and instrumentation, ensuring compliance and accuracy.
• Ensure thorough sanitization activities within the department are carried out consistently.
• Assist Quality Assurance with investigations relating to out-of-specifications, deviations, CAPA, incidents, complaints, recalls, and validations as needed.
• Label raw materials, intermediates, and APIs correctly at each process stage and store them segregated under recommended storage conditions to avoid quality impact.
• Perform regular stock reconciliations.
• Take on additional duties as assigned by the Production Head.

Candidate Requirements

• Educational background: B.Tech in Chemical Engineering or MSc in Chemistry.
• Familiarity with cGMP standards and safety protocols.
• Experience in production planning and execution within API or bulk drug manufacturing environment is beneficial.

Additional Information

Preference will be given to candidates who come through references. The role is based on-site in Nanjangud, Mysore.