Quality Assurance Manager

Dubai, UAE, 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.
The position is based in Dubai, UAE and will report directly to the
Quality Head.
Your Responsibilities will be :
* Ensure site compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), while maintaining the highest standards of data integrity and accuracy.
* Ensure all time readiness of the site for regulatory inspections, to assure consistent and satisfactory inspection outcomes demonstrating substantial site compliance with cGMP.
* Ensure that internal audits of all six quality subsystems are conducted as per schedule and audit findings are addressed in in timely and compliant manner.
* Ensure supplier audits are conducted as per schedule and monitor performance of all supplies, i.e., APIs, Printed packaging materials, contract laboratories, warehouses, and third-party manufacturers.
* Ensure that all personnel at site are trained to effectively execute their roles and responsibilities to develop quality culture at site.
* Ensure all changes are evaluated, implemented, and monitored as per the change control procedure.
* Administer and lead the site Quality System Management Reviews and set improvement areas.
* Design and execute continuous improvement initiatives to enhance product quality, compliance, drive efficiency and cost effectiveness at the site.
* Prepare and monitor site quality assurance budget.
* Responsible for overall Quality Assurance Activities. Responsible for batch release / rejection.
* Evaluate, approve / disposition of non-conformances, corrective and preventive action (CAPA).
* Responsible for overall monitoring of quality assurance with respect to validations.
* To ensure compliance to validation master plan & to ensure its effective validation on changes.
* Oversee all validation activities viz; equipment, utilities, and process (cleaning and process validation) in the facilities.
* Implement and follow procedures related to quality management system.
* Responsible for approval of quality risk management exercises.
* Review and approve of OOS, OOT, market complaints, recall and investigations.
* Responsible for approving validation procedures, reports and establishing revalidation program.
Responsible for annual product quality reviews.
* Ensure compliance with technical and quality agreements. Handle customer and regulatory inspections. Act as management representative for quality management systems.
* Lead, manage, inspire, and motivate the quality assurance team. Continuous upgradation of knowledge with respect to current cGMP and regulatory guidelines.
Your Profile :
* Bachelor's/Master's in pharmacy with ‎12-‎15 years experience.
* Working knowledge of Microsoft excel, word and PowerPoint.
* Relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance and/or Quality Control.
* Experience managing team.
* Experience with health authority inspections and third-party audits
* Understanding of pharmaceutical manufacturing and laboratory work (including familiarity with various analytical techniques) a strong asset.
* Decision-making, Technical Writing & Problem Solving skills.
* Excellent communications skills in English (verbal, written, listening, email writing)
* Understanding of manufacturing processes and/or quality systems element.
* Data analysis skills are required.
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.