This is a privately owned pharmaceutical manufacturing company with a number of production lines including solid dosage form, liquid, semi-solid and suppositories, with 80 registered products. Internationally, the company is GMP compliant and moving towards registering some of its products within EU. Responsibilities:
- Strategic Planning of the Division’s different departments with regard to activities and projects to include R&D Dept, Regulatory Affair unit, Production Dept, and Engineering Dept.
- Approval of validation master plan and subsequent implementation with regard to company’s instruments, production machinery, and facility’s manufacturing environment.
- Representing the company in a joint project between Jordan and EU in order to prepare and upgrade the Jordanian pharmaceutical manufacturing companies to comply with the EU GMP standard, as a first step towards registering the Jordanian medicinal products in EU.
- Head of product dosage form design & development committee.
- Drawing the company’s regulatory affair strategic plan and follow-up.
- Approving the bioequivalence study protocol to be undertaken by CRO to comply with the international regulatory requirements.
- Close follow-up with regard to development in rules and regulations as issued by MHRA and EMA. Relevance of these new rules and regulations to the company’s current activities and methodologies is judged and determined.
- Acting as an expert to write up the Quality Overall Summary (QOS) of the CTD dossier. Recruiting qualified technical personnel and subsequent appraisal of performance.
- Representing the company in a number of high level meetings that are of direct interest to the company.
- Giving presentations about the company, research projects and manufacturing activities to high level delegates and executives visiting the site.
- Recruiting qualified technical personnel and subsequent appraisal of performance.