Shire QA Associate in Amsterdam, Netherlands

The QA Associate will work for the Quality Assurance, batch disposition, part of the Shire external manufacturing Plasma operating unit. This unit oversees external manufacturing commercial and clinical activities, contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of Shire Plasma operating unit.

The QA Associate is responsible for batch review and coordination of product release activities at Shire Contract Manufacturing Organizations (CMO)

This position will be key in managing the CMO relationship, in particular to ensure completeness and compliance of records / documentation to ensure timely disposition and / or release of the product

The person :

Reviews and/or approves CMO provided documents, such as master batch records, executed batch records and deviation investigations.

Prepares and reviews batch release risk assessments

Prepares and approves batch disposition documentation (eg. shipment authorization)

Prepares reports, maintains quality metrics (in particular related to release processes) and makes recommendations to management.

Coordinates timely commercial and clinical product disposition to global markets

Implements adequate communication processes and maintain CMO partnership Authors, revises and/or reviews Shire Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned.

Maintain Shire required QMS databases. Assist in the preparation of Annual Product (Quality) Reviews (APR/APQR), complaint investigations, change controls as assigned;

We are looking for someone with

Minimum of 5 years experience in a QA/compliance related position within the pharmaceutical or life-sciences industry.

Knowledge and understanding of EU and US cGMP regulations with respect to the production and testing of pharmaceutical and/or biological products.

Strong track record of identifying and correcting compliance issues and implementing process improvements.

Demonstrated experience working with and preparing SOPs.

Clear experience working with/improving pharmaceutical Quality Management Systems.

Minimum requirement of a bachelor degree in Sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.).

Desired:

Experience working with contract manufacturing

Experience interfacing with regulatory bodies and working on regulatory submissions.

Knowledge of/experience with aseptic processing and biologicals is desirable.

High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor).

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.