Job Description
Natrix Sciences Ltd. operates an EU GMP licensed pharmaceutical facility producing generics. The company is a Contract Development Manufacturing Organisation (CDMO) specialising in Modified Release Solid Oral Dosage Forms in powder, granules and pellets to be filled into hard gelatine capsules.
In recent years Natrix Sciences has positioned itself to facilitate innovative research and development projects from emerging industries. As a result, Natrix Sciences entered into a joint venture with Zenabis Global Inc. with the incorporation of ZenPharm Limited which is licensed for the production of medicinal cannabis and is well-positioned to be a local leader in medicinal cannabis industry.
Candidates will be given a unique opportunity to practice their current knowledge of quality assurance principles within the generic pharmaceutical industry as well as gain experience in the medical cannabis industry.
Main Objectives of the Job:
- To actively participate in the process of creating and managing an effective quality management system.
Specific Duties and Responsibilities of the Job:
- To keep a log of all QA documentation, including filing and retrieval.
- To register, process, approve and distribute QA documents.
- To draft, format, issue and distribute Standard Operating Procedures (SOPs) and other GMP documents.
- To issue batch documentation and compile documents for review and release of batches.
- To plan, organise, facilitate and maintain training programs, including training matrix and training files.
- To manage and maintain the change control and deviation process, including registration and tracking of follow-up actions.
- To handle and analyse supplier complaints.
- To perform internal audits.
- To support in the Quality Risk Management system to ensure that any risks are adequately identified, mitigated and controlled.
- To support production and quality investigations, root cause analysis and remediation activities.
- To assist with the issue and update of raw material and finished product specifications.
- To assist in the supplier approval process.
- To assist in the preparation of Product Quality Reviews (PQRs), Annual Quality Reports (AQRs) and other relevant quality documents.
- To participate in continuous improvement projects.
Requirements:
- Ideally a Bachelor’s degree level qualification or equivalent (MQF level 6) in a Science-related discipline, preferably in Pharmaceuticals, Biology and / or Chemistry. Hands-on job experience in QA would be considered (and valued highly) in the absence of a formal degree.
- Proficiency in the use of Microsoft Office tools.
- CEFR B2 (Upper Intermediate) in English.
- Experience within the pharmaceutical industry is considered an asset.
The ideal candidate will be capable of working efficiently and effectively, be a good team player and be able to work under pressure. The chosen candidate must exhibit strong interpersonal skills and willingness to learn continuously, be well-educated, and organized, have an eye for detail and have good communication skills.
