Executive - Downstream

**[Exp: 2 to 5 years]**

We are looking for an experienced and detail-oriented professional to support downstream operations in a Bulk Manufacturing (BM) facility for small molecule API production. The role involves equipment handling, documentation, compliance, and coordination with cross-functional teams to ensure efficient and cGMP-compliant manufacturing processes.

**Key Responsibilities**:

- Facility readiness, monitoring, and routine maintenance; ensure operational efficiency of key equipment including mixing vessels, centrifuges, AGR, GLR, SSR.
- Participate in shift operations to support continuous manufacturing activities for small molecule APIs.
- Prepare, review, and maintain process-related documentation including MFRs, BPRs, SOPs, protocols, and other downstream process documents; ensure timely submission and closure.
- Good understanding in chemical engineering concepts like Extraction, Distillation, TFF, Column chromatography, Centrifugation, Filtration, Drying
- Manage Quality Management System (QMS) activities, including initiation and closure of change controls, deviations, and CAPAs related to bulk manufacturing.
- Track and manage inventory of raw materials and consumables used in the manufacturing process.
- Adhere to and promote safety protocols and proper use of PPE within the bulk manufacturing environment.
- Support the scale-up and execution of development batches in coordination with R&D
- Coordinate with the engineering team and external vendors to track and complete preventive maintenance and calibration activities for downstream equipment and instruments.
- Ensure compliance with Good Documentation Practices (GDP) and cGMP standards in all facility and process operations.
- Liaise with vendors for equipment and instrument qualification, troubleshooting, and resolution of technical issues related to downstream processes.
- Collaborate with internal stakeholders and actively participate in technical and safety training to ensure seamless production operations.
- Expertise in handling aseptic operation and critical equipment’s in downstream process.
- Ensure compliance with quality management systems.
- Must have knowledge on GDP, GMP practices during batch operation in commercial campaign.
- Must have work experience in manage the team

**Industry Type**: Pharmaceutical & Life Sciences

**Department**: Production, Manufacturing

**Employment Type**: Full Time, Permanent

**Education**:Diploma/B.Tech/MSc/ in Chemistry/Chemical

Pay: ₹10,000.00 - ₹25,000.00 per month

**Benefits**:

- Provident Fund

Ability to commute/relocate:

- Pondicherry, Puducherry: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Pharmaceutical: 3 years (required)
- Life science: 3 years (required)
- Analytical chemistry: 3 years (required)
- Chemical engineering: 3 years (required)

Work Location: In person