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Qc Microbiology Section Head

4 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 +22 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 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).

VACANCY:
We are recruiting professional caliber to join the team as per the following details:

- Designation: Microbiology Section Head
- Location : MultiCare For Pharmaceutical Industries Manufacturing Site - The Industrial Zone, 03rd Settlement, New Cairo ( Kattamia)
- Reporting : QC Manager
- Grade: fQc01/fQc03

Job Purpose:
This position is centered on the supervision of the QC Microbiology & Environmental Monitoring to ensure effective and efficient laboratory testing is performed by support staff while simultaneously ensuring compliance to pharmaceutical regulations, safety standards, and environmental policies

A. ESSENTIAL DUTIES and RESPONSIBILITIES:

- Manage the Microbiology Laboratory ensuring that the equipment is functional (calibrated and well maintained) and suitable for analytical testing
- Manage workload and resources to ensure timely release of product. Manage the sampling and analysis of raw materials, intermediates, finished products, routine monitoring samples and others. Ensure that testing is carried out in compliance with specifications, Pharmacopoeia requirements and the cGMP and analyze the trend of the analytical results. Ensure the OOS investigation is conducted properly
- Ensure that Reference Standards as well as Standard Solutions are suitable and maintained according to the cGMP. Maintain and control the inventory of test material and consumables, including toxic reagents, ensuring that the budget is respected
- Release the Raw materials, Packaging materials and Semi-product(Imported) according to the test results
- Implement GAP analysis for global requirement and local authority standard and take CAPA actions
- Identify significant adverse quality trends by preparing and analyzing summary reports and key process indicators. Addresses quality control test results, microbial profiles of environmental areas, and customer complaints
- Keep close relationship and communication with other departments to ensure proper execution of the production plan. Lead and motivate the analysts for a continuous improvement of GMPs as well as HSE awareness. Be the Safety contact for the Laboratories
- Assist QC Manager in planning and prioritizing resources allocation to meet test requirements
- Responsible for training staff and overseeing and reviewing documentation
- Lead microbiological analysis of raw materials and finished products, environmental monitoring, water analysis, reviving of pathogenic microorganisms and different microbiological studies
- Ensure L1 Self Inspection procedures for area of responsibility are in place and in use
- Revise/update/draft Standard Operating Procedures (SOPs) governing the departmental activities
- Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
- Generate trend reports as they relate to quality testing
- Ensure sample submission for external testing
- Perform visual inspection of finished product, as needed
- interact with internal departments, including Production, Facilities, Quality Assurance, Validation, Calibration, Materials, and Logistics as needed
- Ensure that an adequate supply of inventory levels is maintained
- Ensure that all documentation is neat and orderly and maintain all necessary documentation
- Conduct special studies as required and maintain inventory control
- Identify and implement issues and opportunities for improvements driven by continuous improvement inclination
- Supervise the collection and evaluation of incident report and change control data and ensures the necessary corrective actions