Quality Assurance Manager - Jeddah, المملكة العربية السعودية - Acino

    Acino
    Acino Jeddah, المملكة العربية السعودية

    منذ أسبوعين

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    Quality Assurance Manager

    Jeddah, Saudi Arabia, 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 Jeddah, Saudi Arabia reporting directly to the Country Manager, KSA and will be responsible to :

    Your Responsibilities will be:

  • In-depth knowledge of cGMP& cGLP& cGDP
  • 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 the META region.
  • Participate in Authority site inspections and follow-up on observations.
  • Responsible for all Quality-related activities in KSA.
  • Control batch records and release batches timely
  • 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 KSA employees.
  • Experience in department management and strong people manager
  • Proficiency with personal computers, business and technical software
  • Can work self-organized as well as with remote organizations
  • Excellent organizational, time management, and prioritization skills
  • Ability to work in an international environment using effective interpersonal, networking and negotiation skills.

    • Your Job Profile will be :

  • University degree in Pharmacy, Chemical Engineering or Chemistry
  • Minimum of 5 years' experience in Pharma QA experience is required
  • Excellent communication skills in English& Arabic
  • Excellent working knowledge of MS Office (Outlook, Word, Excel, PowerPoint).

    • 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.