Quality (Qc/qa) Director - Pharmaceutical

**MultiCare** Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions.

**MultiCare** is a well-established Pharmaceutical Company with diversified scope in both manufacturing and marketing of pharmaceutical products, supplements, cosmetics and medical devices. MultiCare has +21 years of prominent existence in the local market and has almost +69 products marketed and more to come through the pipelines. **MultiCare** Egypt for Pharmaceutical Industries is the manufacturing facility which located at the Industrial Zone - New Cairo and its HQ close by the facility at New Cairo as well. We are one of the fast-growing Pharmaceutical Companies in the market which has strong ambition and aspiration to be one of the key players not only in Egypt but also within the region.

Our international alliances are effective in different countries, including Saudi Arabia, United Arab of Emirates, India and New Zealand with future aspiration to extend more business associations and affiliations in near future to further markets. Recently Multicare Poland has been launched which will be the entry port of the business to the European Union (EU).

**Job description**

Quality is at the heart of everything we do at Multicare Egypt for Pharmaceutical Industries. We are installing additional production lines to join the existing one, namely the Semi-Solid and Soft Gelatin Capsule Production Lines. With such significant expansion we are searching an exceptional profile to lead both Quality Control and Quality Assurance Functions.

**Vacancy**:

- **Designation**:Quality Director
- **Location**:New Cairo
- **Grade**:qD01/qD02
- **Reporting**:Plant Head

**Job Purpose**:
To manage all quality related activities in **MultiCarer's** Site including both arms of QC and QA ensuring regulatory compliance. The scope covers any action that potentially impacts final product quality.

**A.Essential Duties and Responsibilities**:

- Manage, coordinate and approve the execution of the analytical activities for the batch release and all other activities of QC department
- Promote the quality improvement of QC department and assure the adequacy of the relevant SOPs to cGMP
- To ensure that all required chemistry testing for utilities, raw materials, manufacturing processes and products are analyzed and approved timely in accordance with Good Manufacturing Practices (GMP), corporate, regulatory and external agency regulations.
- Plan the presence, shifts, performances and training of the QC & QA Teams to ensure meeting the demand of the production plans
- To provide guidance, support and technical expertise for QC testing and monitor results and issue corrective actions when appropriate.
- To implement reliable methods and (re)validate them.
- Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance to site procedures and regulatory requirements.
- Maintain and support computer systems and laboratory equipment.
- Review, revise and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, Quality Management Systems (QMS), Analytical Technical Standards (ATS) and pharmacopoeia.
- To be up-to-date with the regulations concerning biopharmaceutical QC activities.
- Assure all areas of responsibility are operated according to all safety regulations, procedures and expectations
- Conduct effective training for laboratory staff on computer systems/equipment, methods, specifications and procedures
- Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, analytical method validation protocols and reports, analytical method transfer protocols and reports, change control documentation, certificate of results, certificates of analysis, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements
- To lead and delivery improvement initiatives/projects to improve laboratory operational efficiency and GMP performance
- Recruit, interview, and hire laboratory personnel and provides developmental opportunities for laboratory personnel
- To manage investigation of non-conformities in determining root causes and recommend and coordinate appropriate corrective actions to quality problems in conjunction with other departments
- To identify/ report/ resolve/ escalate issues promptly and appropriately
- Ensure the implementation, ongoing monitoring and reporting of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) that drive continual improvement QC and QA organization
- Support and maintain quality systems such as laboratory investigations, d