Officer / Sr Officer - Quality Control (Wet Analysis) - Pithampur

Rubicon Research; Pithampur; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Rubicon Research in India’s Pithampur site is seeking a hands-on Analytical Chemist to perform physical and chemical testing on incoming RM and PMs. You will execute wet lab analyses, calibrate instruments, and ensure GDP-compliant documentation for uninterrupted OSD manufacturing.

The role requires 2–5 years of core analytical experience in regulated pharma labs, with exposure to USP/EP/BP/IP procedures. Willingness to work across shifts and support regulatory-ready documentation is essential.

Qualifications

• Regular Bachelors or Masters in Science (B.Sc / M.Sc) or Pharmacy (B.Pharm / M.Pharm).
• 2–5 years of core analytical testing experience in regulated pharma labs.
• Experience with RM & PM wet analysis for OSd manufacturing.
• Exposure to USFDA/MHRA-regulated environments is preferred.

Responsibilities

• Perform routine physical and chemical testing of RM APIs/Excipients and PMs (primary and secondary).
• Execute wet lab techniques including titrations, limit tests, assays, moisture (Karl Fischer).
• Operate, calibrate, and troubleshoot core wet lab instruments (FTIR, UV-Vis, Karl Fischer, Autotitrators).
• Support material analysis workflows like challenge studies and hold-time testing.
• Prepare and document shelf-life tracking of reagents and standards per SOPs.
• Maintain GDP-compliant logs and ensure data integrity for audits.
• Adhere to GLP, safety guidelines, and EHS policies on the lab floor.
• Meet daily analytical deliverables with minimal supervision to support production timelines.
• Keep RM/PM lab inspection-ready for USFDA/MHRA audits.
• Be flexible to work across all rotational shifts and travel as needed.

Skills

Wet Chemistry

Bench Instrumentation

Pharmacopoeial Compliance

Data Integrity

Communication

Education

Bachelor's/Master's in Science or Pharmacy

Tools

FTIR

UV-Vis

Karl Fischer

Autotitrators

Refractometers

Melting Point

Job description

Role & responsibilities

Purpose

To perform physical, chemical, and wet chemistry testing on incoming Raw Materials (RM) and Packaging Materials (PM) in absolute compliance with GLP and cGMP norms. This role executes routine wet lab analysis, reagent standardizations, and instrument calibrations to ensure uninterrupted material clearance for OSD manufacturing at the Pithampur site.

Responsibilities

• Perform routine physical and chemical testing of Raw Materials (APIs and Excipients) and Packaging Materials (Primary and Secondary) using classic wet chemistry methods.
• Execute wet lab techniques including manual and automated titrations, limit tests, assays, moisture determination (Karl Fischer), and physical characterization tests.
• Operate, calibrate, and troubleshoot core wet laboratory instruments including UV-Vis spectrophotometers, FTIR, Karl Fischer titrators, Autotitrators, Refractometers, and Melting Point apparatus.
• Support specialized material analysis workflows including challenge studies, hold-time studies, vendor sample evaluations, and pharmacopoeial verification testing.
• Prepare, standardize, and document the shelf-life tracking of volumetric solutions, reagents, indicators, and working standards according to SOPs.
• Ensure strict adherence to Good Documentation Practices (GDP) by maintaining real-time, error-free logs of raw analytical data and laboratory worksheets.
• Follow all Good Laboratory Practices (GLP), data integrity principles, and standard laboratory safety (EHS) guidelines on the bench floor.
• Achieve daily analytical testing deliverables with high precision and minimal supervisor support to meet strict production timelines.
• Maintain the RM/PM wet lab in a perpetual state of inspection readiness for upcoming international regulatory audits (USFDA/MHRA).
• Demonstrate complete flexibility to work across all rotational shifts and travel to alternative plant locations based on business priorities.
• Perform auxiliary lab tasks and tactical testing assignments as directed by the section Assistant Manager or Quality Control HOD.

Required Skills

• Wet Chemistry Techniques: Hands-on proficiency in executing classic chemical identification tests, limit tests, and complex volumetric titrations.
• Bench Instrumentation: Practical experience operating and calibrating basic wet lab hardware such as FTIR, UV-Vis, Karl Fischer, and Autotitrators.
• Pharmacopoeial Compliance: Sound understanding of standard testing procedures (STPs) and analytical protocols defined by USP, EP, BP, and IP.
• Data Integrity Frameworks: Strong understanding of current Good Documentation Practices (GDP) and electronic data security policies inside a pharma lab.
• Communication & Collaboration: Adequate written and verbal communication skills required to maintain accurate lab records and align with warehouse/QA teams.

Preferred Candidate Details

• Education: Regular Bachelors or Master’s Degree in Science (B.Sc / M.Sc) or Pharmacy (B.Pharm / M.Pharm) with a background in chemistry.
• Experience Range: 2 to 5 years of core analytical testing experience strictly focused on RM & PM Wet Analysis inside a regulated pharma laboratory.
• Dosage Form Context: Direct familiarity testing materials utilized in the manufacturing of Solid Oral (OSD) dosage forms.
• Regulatory Exposure: Past working experience within a USFDA/MHRA-approved manufacturing company is highly preferred.
• Operational Readiness: Complete willingness to work across all rotational shifts at the Pithampur facility to support production demands.