Analyst /Sr. Analyst/Asst. Manager

5 days ago

Delhi, Delhi, India RECEX Full time ₹ 12,00,000 - ₹ 36,00,000 per year


Job Description:
Key Responsibilities:

· Manage day-to-day operations of the Pharma Instrumentation Section.

· Plan, supervise, and execute testing of APIs, recipients, and formulations using HPLC and other advanced instruments.

· Ensure strict adherence to NABL, pharmacopeia (USP/IP/BP/EP), ICH, and CDSCO/WHO guidelines.

· Perform and supervise method development, method validation, verification, and system suitability tests.

· Maintain, calibrate, and troubleshoot instruments including HPLC, UPLC, GC, UV-Vis, FTIR, ICP-MS, and dissolution testers.

· Review analytical test results, ensuring accuracy, reliability, and traceability.

· Support QA team for internal audits, NABL assessments, CAPA, and data integrity compliance.

· Train and mentor analysts in advanced instrumentation techniques.

· Ensure documentation as per GLP, ALCOA+ data integrity, and regulatory requirements.

· Liaise with clients and provide technical support for method-related and regulatory queries.

· Coordinate with vendors for instrument qualification, AMC, and preventive maintenance.

Qualifications & Skills:

· Master's degree in Pharmaceutical Chemistry, Analytical Chemistry, Pharmacy, or related sciences.

· Minimum 5 & above years of experience in pharmaceutical analytical testing with strong expertise in HPLC & advanced instruments.

· In-depth knowledge of NABL standards, USP/IP/BP/EP pharmacopeias, and ICH guidelines.

· Proven hands-on experience with HPLC/UPLC (must), GC, UV-Vis, FTIR, ICP-MS, AAS, and Dissolution Apparatus.

· Strong experience in method development, validation, and regulatory documentation.

· Experience in data integrity and audit handling is essential.

· Proficiency in CDS (Chromatography Data Systems), LIMS, and regulatory-compliant software preferred.

Key Competencies:

· Expertise in Analytical Instruments (HPLC, UPLC, GC, ICP-MS, etc.)

· Regulatory & NABL Compliance (USP, IP, BP, EP, ICH, WHO)

· Method Development & Validation


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