QC Executive – Analytical

Job Title: QC Executive – Analytical (2 to 4 Years’ Experience)

Industry: Biopharmaceutical
Location: Puducherry
Department: Quality Control – Analytical
Reports To: QC Manager

Job Summary:

We are seeking a motivated and detail-oriented QC Analyst (Analytical) with 2 to 4 years of experience in a regulated pharmaceutical or biopharmaceutical QC laboratory. The role involves performing analytical testing of raw materials, in-process samples, and finished products in compliance with cGMP and regulatory requirements.

Key Responsibilities:

• Perform routine and non-routine analytical testing of:
• Raw materials, intermediates, in-process, finished products, stability samples
• Water and cleaning validation samples (if applicable)
• Operate and calibrate analytical instruments such as:
• HPLC, GC, UV-Vis, FTIR, Karl Fischer, pH meter, Dissolution, etc.
• Prepare and review test records, logbooks, and related documentation as per GMP and data integrity standards.
• Conduct analysis as per pharmacopeial methods (USP, EP, IP, JP)
• Support in method validation/verification and equipment qualification activities.
• Review and interpret analytical results and escalate OOS/OOT results promptly.
• Maintain compliance with laboratory SOPs, GLP, and safety procedures.
• Participate in stability studies, trending data, and document control activities.
• Support investigations, deviations, and implementation of CAPAs related to QC analytical operations.
• Participate in internal and external audits and regulatory inspections.

Qualifications:

• M.Sc. (Chemistry, Analytical Chemistry, Biotechnology) / B.Pharm / M.Pharm
• 2 to 4 years of hands-on experience in QC Analytical in a cGMP-compliant pharmaceutical or biopharma lab

Key Skills:

• Handling of oncology molecules is plus
• Proficient in handling HPLC, GC, and other analytical instruments
• Familiarity with pharmacopeial testing (USP, EP, IP)
• Good understanding of cGMP, GLP, and data integrity practices
• Strong documentation and observation skills
• Working knowledge of LIMS or electronic data systems is an advantage

Job Type: Full-time

Pay: ₹11,407.45 - ₹27,703.75 per month

Benefits:

• Provident Fund

Experience:

• Laboratory: 3 years (Required)
• Clinical laboratory: 3 years (Required)
• Laboratory procedures: 3 years (Required)
• Laboratory techniques: 3 years (Required)

Work Location: In person