Role & responsibilities To lead, manage, and oversee daily operations within the Raw Material (RM) and Packing Material (PM) Wet Lab section. This role ensures the timely sampling, testing, and release of incoming materials while strictly adhering to cGMP, GLP, and global regulatory standards (such as USFDA, MHRA, and WHO).

1. Section Leadership & Team Management

- Lead and manage a team of 10 QC executives and analysts, distributing workload efficiently to meet manufacturing deadlines.
- Review and approve analysis reports for Raw Materials (active pharmaceutical ingredients and excipients) and Packing Materials.
- Train and mentor team members on analytical techniques, safety protocols, and Valuable Laboratory Practices (GLP).

2. Wet Lab Operations & Technical Expertise

- Oversee routine wet chemistry testing, including titrations, limit tests, physical characterization, and identification tests.
- Supervise the operation, calibration, and troubleshooting of core laboratory instruments (e.g., UV-Vis, FTIR, Karl Fischer, Autotitrators, Melting Point apparatus).
- Manage the preparation, standardization, and shelf-life tracking of laboratory reagents, volumetric solutions, and working standards.

3. Data Integrity & QMS Compliance





- Ensure absolute data integrity by performing real-time online review of laboratory logbooks, raw data, and analytical worksheets.
- Lead investigations for laboratory deviations, Out of Specification (OOS), and Out of Trend (OOT) results in the RM/PM section.
- Implement robust Corrective and Preventive Actions (CAPA) to reduce laboratory errors and prevent recurring issues.

4. Regulatory Audit Support

- Maintain the RM/PM section in a continuous state of audit readiness for international regulatory inspections (USFDA, MHRA, EU-GMP).
- Defend analytical data, laboratory practices, and validation documentation during internal and external compliance audits.

Preferred candidate profile

- Education: B.Pharm / M.Pharm / M.Sc in Analytical Chemistry.
- Experience: 10 to 15 years in regulated pharma QC, with proven experience leading a team of 10+ analysts.
- Core Expertise: Daily operations, sample distribution, and troubleshooting in the Raw Material (RM) & Packing Material (PM) Wet Lab.
- Technical Skills: Deep knowledge of Wet Chemistry, Pharmacopoeias (USP/EP/IP), and lab instruments (FTIR, UV, Karl Fischer).
- Compliance & QMS: Strict adherence to Data Integrity (ALCOA+), handling lab OOS/Deviations, and facing USFDA/MHRA audits.

📌 Asst Manager - Quality Control (RM & PM Testing) (Wet section Lead)
🏢 Rubicon Research
📍 Pithampur