Analyst /Sr. Analyst/Asst. Manager

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