Job Description :
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Responsibilities
- To perform QC testing of raw materials, incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies.
- To support equipment qualification (if required).
- To perform and coordinate monitoring, calibration, and maintenance of laboratory equipment.
- To lead the preparation of technical documentations such as protocols, position papers and risks assessments.
- To perform write up for laboratory investigations, deviation and on time closure in line with Quality Management system procedures. (if required)
- To support method transfer/verification/validation for new product introduction.
- To perform periodic reviews for laboratory documents (e.g., SOPs, test methods) to ensure current, accurate and reflective of actual practices.
- To manage QC chemicals and consumables inventory stock check.
- To maintain the accuracy, completeness, and compliance of laboratory data.
- To participate in continuous improvement activities.
- To maintain own training records.
- To communicate effectively with cross-functional team and participate in problem solving activities.
- To guarantee the application and adherence to cGMP in their field.
- Be flexible to support shift work patterns (e.g., staggered shifts, weekend work) as required by business needs to ensure uninterrupted laboratory operations.
- Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab.
- Support and encourage a Quality Culture and company 4i values throughout QC.
- Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.
- To work with HSE, cGMP and 5S in mind at all times.
- Undertake ad-hoc activities that may be required by the business.
Knowledge and Skills:
- Ability to work independently with minimal supervision and adhere to critical timelines in a fast-paced environment.
- Effective verbal and written communication skills, with the ability to interact at all internal and external levels, including during regulatory audits.
- Excellent attention to detail with a rigorous approach to data recording and analysis.
- Excellent organisational and time-management skills, with the ability to prioritize multiple tasks effectively.
- Strong analytical thinking and systematic problem-solving skills.
Education and Work Experience:
- Degree in Chemistry
- At least 2 years Pharmaceutical industrial experience.
- Proficiency in implementing GMP regulations and adhering to various international standards throughout all facets of the role.
- Demonstrated ability to apply GMP regulations (FDA, EMA, etc.) and other international guidelines to all aspects of the work.
- Hands-on experience with analytical techniques such as HPLC, GC and dissolution
- Proven experience in writing technical documentation and conducting laboratory investigations.
