Executive, Manufacturing Process Operations

0 years

0 Lacs

Posted:2 days ago| Platform: SimplyHired logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Description:

This role will be responsible for managing solvent recovery operations in line with cGMP, EHS, and quality standards. The role involves overseeing the recovery, purification, reuse, and proper disposal of solvents used in API manufacturing, ensuring cost efficiency, regulatory compliance, and safe handling practices.

Essential Functions:

Supervise the operation of solvent recovery units including distillation columns, condensers, and vacuum systems.

Monitor solvent input, recovery yield, quality specifications , and ensure reuse as per production requirements.

Coordinate with QA/QC to ensure the analytical clearance of recovered solvents.

Maintain records of solvent usage, recovered quantities, purity levels, and waste generation .

Ensure compliance with cGMP, GDP, and EHS protocols in all solvent recovery processes.

Manage storage, segregation, and labelling of solvents (fresh, recovered, and waste).

Identify and troubleshoot process deviations or equipment malfunctions in the recovery system.

Collaborate with the production team for timely availability of recovered solvents.

Lead initiatives to improve recovery efficiency and reduce solvent losses.

Maintain and update SOPs, logbooks, and cleaning records related to solvent recovery.

Ensure training and safety awareness for operators handling solvents and equipment.

Support internal and external audits and inspections by providing necessary data and documentation.

Additional Responsibilities:

Ensure compliance with local and national environmental regulations for solvent recovery and waste disposal.

Assist in solvent recovery plant commissioning, scale-up activities , or new equipment validation when required.

Maintain inventory of recovered and fresh solvents , and ensure accurate reconciliation with production consumption.

Participate in internal, regulatory, and customer audits , and provide documentation and clarifications related to solvent recovery processes.

Skills & Competencies:

Expertise in solvent distillation, fractional recovery, and chemical compatibility.

Hands-on experience in solvent recovery equipment operation and maintenance.

Strong understanding of cGMP, EHS norms, and hazardous material handling.

Good documentation and communication skills.

Implementing corrective actions.

Working knowledge of ERP systems (e.g., SAP) is preferred.

B.Sc. / M.Sc. – Chemistry

Diploma / B.Tech – Chemical Engineering

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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