Job Description
Natrix Sciences Limited operates an EU cGMP licensed pharmaceutical facility producing generics. The company is a Contract Development Manufacturing Organization (CDMO) specializing in modified-release solid oral dosage forms in powder, granules, and pellets to be filled into hard gelatine capsules. In recent years, the company has expanded its capabilities to support innovative research and development projects in emerging industries. Additionally, Natrix Sciences provides services to ZenPharm Limited, which holds a license to test and package medicinal cannabis and is in a position to become a local leader in this sector.
We are seeking a self-motivated, dynamic individual with strong leadership skills. The ideal candidate will be adaptable, resilient, and possess a ‘can-do’ attitude. We value individuals with a commitment to continuous learning and professional growth within the company.
Specific Duties and Responsibilities
Reporting to the Head of Quality or relevant senior management, the successful candidate will:
- Manage the daily activities of the QC laboratory, ensuring compliance with cGMP, cGLP, and Eudralex Volume 4 GMP guidelines.
- Lead and supervise the QC Team providing guidance and mentorship.
- Oversee the sampling and analysis of raw materials, intermediates, finished products, and stability samples, ensuring all testing is performed accurately and in a timely manner.
- Ensure the laboratory meets all safety, environmental, and regulatory requirements.
- Take responsibility for the development, validation, and transfer of analytical methods for routine testing, method validation, and method transfer projects.
- Perform quality reviews of analytical data, method validation reports, and related documentation, ensuring accuracy, compliance, and timeliness.
- Implement and manage lab investigation procedures in case of out-of-specification (OOS) or out-of-trend (OOT) results.
- Participate in external audits and liaise with regulatory authorities as required.
- Ensure appropriate procurement and inventory management of laboratory supplies.
- Contribute to continuous improvement initiatives within the laboratory to enhance efficiency, quality, and compliance.
Requirements
- A degree in Chemistry, Biology, Pharmaceutical Sciences, or a related science discipline.
- Minimum of 5 years of experience in a GMP-regulated laboratory, with at least 2 years in a leadership or supervisory role.
- Strong experience in analytical method validation and analytical method transfers.
- Comprehensive knowledge of GMP and GLP standards and requirements.
- Excellent time management, problem-solving, and decision-making skills.
- Strong communication skills, both oral and written, with the ability to convey complex technical concepts clearly.
- Proficiency in Microsoft Office (Word, Excel, Outlook) and relevant laboratory software.
- Ability to lead, motivate, and mentor a team in a fast-paced environment.
- In possession of an EU working VISA.
