QA Compliance Section Head

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 is close by the facility as well in New Cairo. 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).

**Vacancy**:
We are recruiting an expert professional to join the QA Team as Quality Compliance Section Head as per the following details:

- **Location **:New Cairo
- **Reporting**:QA Manager
- **Grade**:qAc01/qAc03

**Job Purpose**:
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to procedures. Evaluate and provide QA recommendations on all products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements.

**A.Essential Duties and Responsibilities**:

- Ensure a constant state of inspection readiness and that all audit observations are addressed quickly and completely to maintain readiness levels
- Complete minor and major incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas. Provide input and guidance to the team conducting the investigation. Make recommendations to department management regarding results of investigation and process improvements, when necessary. Make final recommended batch disposition. Manage the CAPA system to ensure that corrective and preventative actions are made and followed
- Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to Management Team, recommend appropriate corrective actions when necessary, and perform necessary follow up with respective functional area management to ensure cGMP audit observations are implemented
- Provide support to functional areas regarding the Change Control System by providing assessments, work closure, and follow-up. Recommend documentation and supporting data to include in the Change Control Request to ensure that enough information is provided to so that an informed decision can be made
- Promote a highly safety conscious culture and EHS focused workforce
- Represent QA on key forums and teams to evaluate and provide QA recommendations on products, systems, and issues that are affected or may be affected by regulatory or cGMP requirements for any proposed changes or new information
- Perform all job responsibilities in compliance with applicable regulations, current operating procedures and industry practice
- Participate in investigations of escalations, lead the investigation report preparations and follow up all necessary actions
- Prepare annual site Self-Inspection plan and ensure activities are completed on-time
- Maintain document control system (issuing, reviewing, updating and canceling) for all company processes including Standard Operating Procedures (SOPs) and Master Production Batch Records
- Identify key manufacturing risks across different functions and devise mechanisms to mitigate them
- Drive investigations of Critical Deviations & Complaints as a member of Quality Compliance team and provide guidance on related topics

**B. Job Requirements**:

- Bachelor’s degree in science or related discipline (e.g. Chemistry, Pharmacy, etc)
- Professional knowledge and experience of GMP and Total Quality Management System
- Strong verbal and written communication skills
- Strong analytical and problem-solving skills
- Proficient to advanced Microsoft Excel skills; Microsoft Access skills a plus
- **At least 8-10 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, in which at least 3 year in Quality Compliance Managerial

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