Quality Assurance Manager, Egypt

Cairo, Egypt, Middle East, Turkey, and Africa

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery
technologies. We have a clear focus on selected emerging markets in the Middle
East, Africa, the CIS Region and Latin America, and operate in some of the
most dynamic countries of the world. We value courage, commitment, trust and
empathy and provide an environment that supports initiative and effort. We are
proud to be action oriented and open-minded, with a strong focus on quality
and product availability, even in remote and hard to reach areas of the world.
This position is based in Cairo, Egypt and will report directly to the
Regional Quality Assurance Director, META. The role will be responsible
for managing, leading and implementing the Quality Assurance function, Quality
strategy and activities in Egypt.
Your Responsibilities will be :
* Perform and document QA Due Diligence on distributors and service providers according to corporate process.
* Monitor and report monthly KPIs such as audit execution vs plan, implementation of QMS.
* Keep up-to-date with the relevant regulations, quality directives and guidelines.
* Coordinate, organize and execute external GDP/GMP customer audits within Egypt.
* Participate in Authority site inspections and follow-up on observations.
* Responsible for all Quality-related activities in Egypt.
* Control batch records and release batches in a timely manner.
* Create and maintain the local Quality Management System (QMS) including Master documents, SOPs etc.
* Create/approve deviation, CAPA, change control, complaint reports or other quality relevant documents.
* Perform risk assessment of supplier's and distributor's qualification, which is required for the preparation of the annual audit plan.
* Implementation of QMS, TQAs and all other Quality related documents. Create, review and negotiate Technical Quality Agreements with contract manufacturing organizations and service providers.
* Assessment of PQRs.
* Coordinate product launches and transfers from QA perspective.
* Support quality training to all Egypt employees.
Your Profile :
* University degree in natural sciences (e.g. pharmacy, chemistry)
* Minimum ‎8 years of experience in Quality Assurance in the pharmaceuticals industry
* In-depth knowledge of cGMP, cGLP and cGDP
* Good knowledge of drug laws and current national and international GMP and GxP requirements
* High analytical and process-oriented mindset combined with the capability of understanding complex situations and processes
* Able to work in an international and interdisciplinary environment
* Excellent command of written and spoken English
* Excellent organizational and co-ordination skills
* Excellent communication skills and influencing ability, demonstrates success in building productive relationships with internal and external stakeholders
This is the opportunity to join a very dynamic organization, where decisions
are taken fast and where you can actively participate in shaping our future.
If this sounds exciting, we would love to hear more about you!.
Please note only direct applications via our HR System will be considered.

Further Information

If you are interested in working for a company that offers such challenging
opportunities, we invite you to send your application along with all pertinent
documents - preferably via e-mail in one PDF document to the following email
address:
[email protected]
We are looking forward to hearing from you. Only direct applications are
considered.