Job Overview
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Date PostedAugust 5, 2024
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Expiration date--
Job Description
Excellent Opportunity for in a Leading MNC Pharmaceuticals Company as Upstream Processing Manager – Egypt..
Designation : Upstream Processing Manager..
Location: Egypt
Exp : 10 Years
DEPARTMENT – Pharmaceuticals Industry
REPORT TO : Management
JOB PURPOSE
Summary
Looking for USP Manager to join the Production department and all related tasks, ensuring successful fermentation runs and production to achieve the company’s goals.
Tasks
- Set objectives for the USP department, and supervise their implementation; identify and apply KPIs, and measure their efficiency and effectiveness, to achieve the company’s goals.
- Participate in designing new USP manufacturing areas in manufacturing facilities in compliance with EU GMP standards.
- Lead ramping up and establishing fermentation in XPandC including process automation and participate in line licensing activities (GMP manufacturing license).
- Issue the production plan for the department according to forecast, considering stock of final bulk, and availability of tools, raw materials and consumables.
- Manage fermentation process in all Egypt (all manufacturing sites and expression systems), and manage department staff.
- Supervise the continuous analysis of the production process aiming at process understanding and improvement.
- Build and maintain a strong and capable upstream team for Egypt.
- Create and apply individual development plans and perform evaluations for team members to ensure continuous improvement.
- Strongly cooperate with other departments/ sections within Egypt (for instance DSP, QA, QC, warehouse, engineering), and within (e.g. finances, purchasing, IT, HR) aiming at smooth and efficient production and process flow.
- Ensure the continuous suitability of equipment and its readiness for GMP production for instance by ensuring routine maintenance and calibration according to the defined plan in the department (including external contracting).
- Approve SOPs and MBRs according to revision plan and current needs of processes.
- Supervise recording and reporting of incidents and deviations, investigations and assessments, cause analysis and SMART corrective and preventive actions for audit findings, incidents and deviations, supervise the implementation of CAPA, additional controls, change control actions, annual report actions and management review actions timely.
- Ensure execution of process and cleaning validation as defined in relevant protocols.
- Ensure execution of supplier evaluation to support their qualification for raw materials and consumables used in the production process.
- Perform and organize on-site training sessions.
- Supervise the execution of quality risk management projects.
- Participate in assessing the environmental hazard aspects and impacts for the Egypt USP department, as well as the health and safety risks for this department.
- Responsible for preparing and adhering to the department budget reflecting all USP manufacturing areas and projects.
- Reporting in internal reporting system (IRS)
- Perform any additional tasks as requested in the field of employment.
Qualification:
- Bachelor’s degree in Sciences, Pharmaceutical or Biotechnology Sciences or other related field, with at least 10 years of upstream experience.
- Preferable Masters or PhD in Sciences or Pharmaceutical Science
- Strong computer, scientific, organizational and leadership skills.
- Excellent communication in English (oral and written).
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Willingness to travel
(Egyptian taxes will be paid by the company but any taxes or liabilities in your home country
if they exist will be covered by you)
Plus:
- Accommodation
- 1 Return Ticket for home country per year
- Health Insurance
- The contract duration will be 3 years.
If Interested please contact – 9871008190 , or share resume to hr@mmenterprises.co.in
Regards
Flora Annie Mary
MME