Release Manager Contract Organizations

We are pleased to present this opportunity to you on behalf of our client. They are one of the world's most reputable, Pharmaceutical institutions. This is a great opportunity for you. You will be one of the key people of a large project and will have good exposure in the business.

Focus of the job
The QA release manager is responsible for maintenance of a Quality System for the release of products manufactured by Contract Manufacturing Organizations (CMO).
By applying current international GxP rules as well as Company's internal requirements Release Management ensures GxP release and marketing authorization compliance in contract manufacturing of commercial medicinal products and medical devices. The Release Management is the designated contact for all aspects related to CMO release activities.

Responsibilities

Releases, rejects or quarantines, respectively commercial medicinal products (bulk, semi finished and finished products) and medical devices produced by assigned Contract Manufacturing Organizations (CMO) in the area of the Pharma Supply Chain of the Company on behalf of the Responsible Person.
The release decision is based on:
The terms and conditions set forth in corresponding Quality Agreement(s)
The complete and agreed release documentation issued by the assigned CMO
The analytical results obtained during QC release testing

Ensures quality, patients' safety and regulatory compliance for the release of products with the help of all sources of information relevant for the release decision.

Initiates, evaluates and approves:
GMP relevant documents (eg Master Production Record, Master Data)
Deviations (DR/IR) from manufacturing, quality control/assurance and logistics
Market complaints for products that are released by Release Management Europe

Ensures efficient treatment of quality, safety and compliance issues, which might cause a delay of release taking into account the supply situation, time, costs and the Company's departments involved.
Performs quality and compliance monitoring of assigned CMO related to the release activity.

Participates in:
Internal and external audits
Assists in coordination of customer audits and authorities inspections
Issue Management (Local Quality Review Board and Global Expert Teams).
Assists in the implementation of new regulatory requirements

Supports the development of business oriented problem solutions and establishes decisions in cooperation with Quality Site Managers.

Supports the LoCC CMO regarding changes in Analytics and Manufacturing Is responsible for complaint management and classification of complaints for products that are released by Release Management Europe.

Gives input and reviews APQR for the approval by the Responsible Person.

Provides support for the preparation and the maintenance of Quality Agreements for CMO.

Signs manually issued certificates on behalf of the RP.

This is a great opportunity to grow with an International and reputable organization that offers an exciting working environment. If you fit the specification, please apply!
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