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QA Manager

2 weeks ago

مصر, Egypt Multicare Egypt for Pharmaceutical Industries Full time

**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).

**QA Manager Vacancy**:
Multicare Egypt for Pharmaceutical Industries is seeking for a Quality Assurance Manager as per the following details:

- **Designation **: QA Manager
- **Location **:3rd Settlement, New Cairo, Kattamia (Industrial Area), Cairo
- **Reporting**: Site Manager
- **Grade**: qAm01/qAm02

**Job Purpose**:
To lead the Quality Assurance function through its staff ensuring full and strict adherence and compliance to the the cGMP, Policies, Procedures, and Prevailing local and international guidelines instilling the quality in the heart of everything QA Team do.

**A. Essential Duties and Responsibilities**:

- Lead the efforts of QA personnel responsible for the testing, investigations, and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals
- Responsible for setting strategy direction for the Quality Assurance Dept. and team
- Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support (if any)
- Support team by guidance and coaching and provide direction/approval of activities and decisions
- Cultivate and reinforce appropriate group values, ethics, norms, and behaviors
- Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews
- Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
- Responsible for supporting all planned and unplanned manufacturing and labs deviations, review and approval of product and equipment change controls (including SOPs and master batch records)
- Conduct impact assess to design changes and participate/coordinate CAPA Review Board
- Maintain the structure to ensure that all quality commitments and timelines are tracked and met. In addition, assist the senior leaders at the site in resource and budget preparations
- Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems
- Actively with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues
- Coordinate planned and/or ad-hoc external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan
- Responsible for driving cross-training across Drug Substance, Drug Product, Site staff resources (as well as potentially other areas of QA)
- Work directly with internal and external customers to assure Best-in-Class expectations for quality are met if not exceeded
- Analyze trends, quality metrics and other data to identify quality and compliance gaps
- Participates in the recruitment, selection, promotion, and performance management of QA employees

**B. Qualification/Knowledge/Experience**:
**Level of Education**:

- Pharmacy graduate preferably with related post-graduate QMS degree or otherwise relevant

**Experience**:

- Track record of leading the QA function at sound pharmaceutical organizations

**Language**:

- Excellent verbal, written and interpersonal communication skills. English fluency essential

**IT Literacy**:

- MS-Office

**C. Competencies and Behaviors**:

- Previous experience mentoring and coaching experienced Quality professionals
- Proven results using quality improvement tools and techniques to drive imp