Team Member – QC (Analytical Instrument Engineer)
Roles & Responsibilities
- Ensure smooth operation and availability of QC analytical instruments.
- Plan and execute calibration, qualification, and preventive maintenance activities.
- Troubleshoot instrument breakdowns and coordinate with vendors for timely resolution.
- Maintain instrument lifecycle documentation and qualification records.
- Support method validation, method transfer, and investigation activities related to analytical instruments.
- Ensure compliance with GMP, data integrity, and audit requirements.
- Monitor instrument performance trends and implement improvements.
- Manage spare parts inventory and AMC/CMC activities.
- Lab safety, following JSA (Job Safety Analysis), HIRA and using proper PPE (Personal Protection Equipment) at the workplace are emphasized.
Qualifications
Educational Qualification
- Polytechnic Diploma in analytical instrument or relevant engineering diploma are preferable
- B. Pharma / M. Pharma / B.Sc. / M.Sc. (Chemistry, Analytical Chemistry, Pharmaceutical Chemistry) or equivalent can be apply if having experience in analytical instruments Maintenance
- Additional certification in analytical instrumentation is desirable.
Experience
- 3 to 8 years of experience in a pharmaceutical QC laboratory or analytical services.
- Hands-on experience with troubleshooting, maintenance, qualification, and calibration of laboratory instruments.
Technical Skills
- Expertise in HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus and other QC laboratory instruments.
- Knowledge of instrument qualification (IQ, OQ, PQ).
- Experience in preventive maintenance and breakdown management.
- Understanding of data integrity requirements and computerized systems.
- Familiarity with LIMS, Empower, Lab Solutions, or similar software.
- Knowledge of GMP, GLP, Data Integrity, and regulatory requirements ( CDSCO, EU GMP, WHO).
Behavioral Skills
- Adaptability to manage dynamic challenges effectively.
- Collaboration and teamwork to achieve shared objectives.
- Clear and impactful communication to build strong relationships.
Critical Exposures
- Experience as Digital P&L ownership in pharma / Non-pharma (FMCG, Banking, Consumer Health) industry is desired.
- Exposure to a comprehensive digital media strategy (specific focus on generating more leads, leveraging more digital channels etc) is preferred.
- Experience in marketing analytics and Digital content creation, plus Inbound and Outbound marketing experience is desired
