Key Responsibilities

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accredited laboratory) and ensure all training is completed as per Laboratory Training Program.
• Delivery of key Quality and Performance Objectives.
• Conduct testing according to written procedures - Environmental Control testing (including water/air & surface microbial/air particulate) of controlled areas within the plant, Endotoxin and Bioburden testing (routine/ batch release/ validation) for Microbiology test support; Raw material, in-process and finished product testing for Analytical test support.
• Collect, compile and analyse data and prepare laboratory reports.
• Ensures all notebooks/logbooks/Datasheets are completed and reviewed in a timely manner. Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
• Assist manufacturing/operations/quality in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and out of specification results are documented and reported to Laboratory Management.
• Ensure equipment standards and other materials are approved/released prior to use.
• Performs cleaning, preventative maintenance, verification of instruments and equipment where required.
• Perform new equipment qualifications and requalifications as assigned and write related protocols/reports.
• Support Internal/External Audits.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• To build quality into all aspects of work by maintaining compliance to all quality requirements.
• Perform and assist with additional duties as may be directed by the Supervisor.

Requirements

• Diploma or Bachelor’s Degree in Analytical Chemistry, Chemistry, Pharmaceutical Science, Chemical Engineering, Biotechnology, Materials Science, or other related science disciplines.
• 2–5 years of relevant laboratory experience in an analytical or quality control laboratory.
• Experience in a regulated industry preferred (Medical Devices, Pharmaceutical, Biotechnology, or Chemical Manufacturing).
• Experience with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) is highly desirable.
• Experience performing routine laboratory testing.

Required Skills

• Hands-on experience with analytical instrumentation such as HPLC/GC, FTIR, Dissolution Testing, pH Meter, and Analytical/Micro Balance.
• Sample preparation and handling techniques.
• Calibration, verification, and routine maintenance of laboratory equipment.
• Ability to troubleshoot minor instrument issues.
• Knowledge of method execution according to validated procedures.
• Understanding of GMP, GLP, Good Documentation Practices (GDP), and Data Integrity (ALCOA+ Principles).
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 / Quality Management System requirements is preferred.
• Knowledge of laboratory safety and chemical handling.
• Strong attention to detail and adherence to quality requirements.
• Good communication and teamwork skills.