The Role
Within the company, the main purpose of the QC Analytical Data Reviewer manages, organizes, coordinates and controls the Laboratory Documentation review, training of analysts and EHS issues for QC Laboratory to attain the most effective and efficient deployment of human and material resources within a given budget. 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 audit all laboratory worksheets, calibration protocols/reports and raw data archives to ensure the validity and accuracy of the data.
• To prepare and check Certificates of Analysis for all lots of raw materials and packaging materials tested in the QC Department.
• To provide training and retraining to new or existing laboratory staff on proper laboratory documentation procedures as required and ensure that this is documented according to procedures.
• To coordinate review in order to ensure that all materials are reviewed and released in a timely manner to meet production schedules.
• To act as backup on any archival and sample registration processes when required.
• 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.
Qualifications, Experience & Skills
• A-Level standard in Chemistry or MCAST diploma or Science degree.
• 4 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, troubleshooting 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: hr@pharosmt.mt