Production Manager/Chemist – Haemodialysis Solutions

My client is building a greenfield manufacturing facility near Vilupuram, Tamil Nadu, for haemodialysis solutions/concentrates and is seeking a Production Manager/Chemist to join the team.

The selected candidate will be responsible for day-to-day production activities, preparation and control of dialysis solutions, adherence to approved formulations and SOPs, documentation, GMP compliance, and coordination with Quality Control, Quality Assurance and regulatory authorities.

Key Responsibilities

• Carry out manufacturing of haemodialysis solutions/acid and bicarbonate concentrates according to approved formulations, Batch Manufacturing Records and SOPs.
• Ensure accurate weighing, dispensing, mixing and preparation of raw materials.
• Monitor critical production parameters, including pH, conductivity, concentration, temperature and batch volume.
• Operate and supervise mixing, storage, filtration, transfer, filling and related production equipment.
• Ensure the proper preparation and availability of purified water / RO-treated water required for manufacturing.
• Perform and document in-process checks during production.
• Maintain complete and accurate Batch Manufacturing Records, equipment logs, cleaning records and production documentation.
• Ensure compliance with GMP, hygiene, safety and contamination-control requirements.
• Coordinate with Quality Control for sampling, testing and release of raw materials, in-process materials and finished products.
• Coordinate with Quality Assurance for batch documentation, deviations, CAPA, change controls and SOP implementation.
• Coordinate with CDSCO and other relevant regulatory authorities for licensing, inspections, regulatory submissions, product approvals and ongoing compliance requirements.
• Assist in preparing and maintaining technical and manufacturing documentation required for CDSCO applications, inspections and regulatory audits.
• Work closely with the Regulatory Affairs/Quality team to ensure that manufacturing activities comply with applicable CDSCO requirements and medical deviceregulations.
• Ensure cleaning and sanitisation of manufacturing tanks, pipelines, filling systems and production areas.
• Monitor raw-material consumption, yields, wastage and production efficiency.
• Assist in equipment qualification, process validation, cleaning validation and trial production during commissioning of the greenfield facility.
• Participate in preparation and implementation of production SOPs and work instructions.
• Support regulatory, customer and quality-system audits.
• Train production operators and technicians on manufacturing procedures, GMP and safe handling of chemicals.

Qualification

• B.Sc. / M.Sc. in Chemistry, Applied Chemistry, Industrial Chemistry or a related discipline
• B.Pharm / M.Pharm candidates with relevant manufacturing experience may also be considered.
• BE/ME in Chemical Engineering or Food Technology may also be considered.

Experience

• 2–6 years of relevant manufacturing experience in pharmaceutical, dialysis-product, IV fluid, medical consumable, liquid formulation, chemical or healthcare manufacturing.
• Candidates with direct experience in haemodialysis concentrates or dialysis solutions will be preferred.
• Experience in CDSCO licensing, regulatory inspections or regulatory documentation will be a strong advantage.
• Experience in commissioning or stabilising production in a greenfield manufacturing facility will be an additional advantage.

Candidate Profile

The ideal candidate should be technically sound, quality-conscious, disciplined in documentation and comfortable working in a greenfield manufacturing environment. The candidate should be willing to take hands-on responsibility during commissioning and production ramp-up and work closely with Production, QC, QA, Engineering, Regulatory teams and CDSCO / other statutory authorities as required.

Candidates with experience in haemodialysis concentrates, dialysis fluids, IV fluids, pharmaceutical liquid formulations or medical consumables are particularly encouraged to apply.