Within the company, the main purpose of the Quality Control Laboratory Analyst is to perform analysis and reporting of samples and may be assigned to any section such as raw material, finished product, validation, microbiology or stability, performs equipment calibration, documentation review, and confirmatory analysis within investigations, participates in internal quality systems including training. This must be achieved through efficiency both in time and material resources, while ensuring compliance with cGLP, company procedures, EH & S regulations as well as Pharmacopoeia standards.
Role & Responsibilities:
• To carry out sampling, analysis of samples, and documentation of the analytical procedures performed according to cGLP and standards.
• To ensure GMP compliance as per local procedures, and EU Eudralex Volume 4 GMP guidelines.
• To ensure compliance with established procedures relevant to the EHS management system in line with the organization’s policies, procedures, international standards and local and EU regulations in the daily operation of the Department.
• To be responsible for maintaining a high standard of GLP, good housekeeping and hygiene in the laboratories.
• To ensure that the equipment is calibrated before use.
• To review the documentation performed before sign-off.
• To ensure that all analysis and equipment usage are logged in appropriately according to cGLP and internal procedures.
• To perform any necessary Analytical Documentation Review in accordance with cGLP in a timely manner.
Qualifications, Experience & Skills
• A 1st degree in Pharmacy, Science or Life Sciences or at least 2 A-Level qualifications including Chemistry or MCAST diploma or Science degree.
• 1-2 years’ Work experience in a QC laboratory with a good understanding of analytical testing and equipment operation / troubleshooting; or an adequate combination of education and experience
• Current Good Manufacturing Practices (cGMP), Good laboratory practices (cGLP), FDA guidelines, and other regulatory requirements.
• Knowledge and understanding of analytical methodologies and instrumentation.
• Possession of good communication, trouble-shooting and function skills.
• Proactive attitude towards work and learning new techniques.
• Good time management skills.
• Good organizational skills.
• Ability to work in a team.
• Principles of Environmental Health and Safety.
• Computer programs and applications.
• Mathematical and statistical skills.
• Ability to communicate clearly and concisely in English, both orally and in writing.
Cv’s to be forwarded to: firstname.lastname@example.org