Asst Manager - Quality Control (RM & PM Testing) (Wet section Lead)

Rubicon Research; Pithampur; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

Rubicon Research in India seeks a Senior QC Leader to oversee the Raw Material and Packing Material Wet Lab operations, ensure timely sampling, testing and release of incoming materials, and maintain strict cGMP, GLP and regulatory compliance.

You will lead a team of 10 QC executives and analysts, review reports, train staff on analytical techniques and data integrity, and ensure audit readiness for USFDA, MHRA and EU-GMP inspections in a fast paced pharma environment.

Qualifications

• 10–15 years of experience in regulated pharma QC.
• Proven experience leading a team of 10+ analysts.
• Deep knowledge of Wet Chemistry and pharmacopoeias (USP/EP/IP).
• Familiarity with GLP, cGMP and regulatory audits (USFDA/MHRA/EU-GMP).

Responsibilities

• Lead and manage a team of 10 QC executives and analysts.
• Review and approve analysis reports for RM and PM materials.
• Train and mentor team on analytical techniques, safety, and GLP.
• Oversee wet lab testing, instrument calibration, and standardization.
• Ensure data integrity through real-time review of logs, raw data, and worksheets.
• Support regulatory audits and maintain audit readiness in RM/PM sections.

Skills

Team leadership

Analytical chemistry

Wet chemistry

Data integrity

Regulatory audits

Education

B.Pharm / M.Pharm / M.Sc in Analytical Chemistry

Tools

FTIR

UV-Vis

Karl Fischer

Autotitrators

Melting Point apparatus

Job description

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 Good 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.