Job Description
Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.
- Main job responsibilities:
- In line with the requirements of the supply chain department provide an effective product release service which ensures that all products released for sale or further processing have a quality appropriate to their intended use, i.e., comply with the export market, local Egyptian and WHO cGMP standards and Product Quality Specifications.
- Handle investigations of deviations, data integrity deviations, complaints, OOS & OOT results, in coordination with compliance manager to assure implementation of appropriate CAPA & investigation closure within the specified time with the intended quality requirements.
- Ensure Quality incidents associated with products manufactured and packed are managed in line with the QMS and cGMP.
- Ensure that there is effective management of investigations (including CAPA) and assessment of data from products failing to meet required standards and make batch disposition decisions on rejection or rework in consultation with the quality operations head, supply chain manager, production manager and factory manager as appropriate.
- As appropriate manage the Quality sign off/approval of all quality-related systems, procedures and documentation utilized within the factory and ensure compliance with WHO cGMP, EDA regulations, QMS requirements and Product Quality Specifications.
- Manage an effective quality assurance team aligned to the manufacturing of products by promoting a culture of task delegation and single touch 'ways of working.
- Be responsible for technical and personal development of direct reports by using effective appraisal and performance management and implement training for quality assurance staff to ensure competence in performing their required function.
- Investigate counterfeit Incidents with a proper escalation in coordination with the Quality operations head.
- Ensure Annual review reports/trends are prepared, reviewed and Issues have been escalated and necessary actions have been taken ex: deviations, complaints, OOS, OOT.
- Increase awareness of subordinates and make the most of using available tools for effective information search and ongoing improvement in ways of working.
- Ensure documentation life cycle management and ensure that data integrity requirements are followed.
- Review and approve risk assessments related to each area in the factory with appropriate controls to minimize potential product quality risks.
- Review & evaluate the APR.
Qualification
- University graduate, pharmacy, or science,
- Years of experience more than 8 years in similar position
- Up to date knowledge of current WHO, FDA, SFDA & EU cGMP, and EDA Regulatory requirements.
- Excellent documentation and report writing skills.
- Excellent verbal and written communication skills.
- Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
- Experienced in handling regulatory interfaces such as inspections.
- Excellent leadership & organizing skills.
- Excellent verbal and written communication skills.
- Good command of English (spoken and written)
- Good Computer and communication skills (Word and Excel)
- Self-motivation, empowerment, and adaptation to business change.
