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 robust 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.
· Robust 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
📌 Analyst /sr Analyst/asst Manager Delhi (India)
🏢 RECEX
📍 India