Shire Quality Assurance specialist in Lessines (Baxalta), Belgium
The purpose of this job is to:
Support the adequate deployment, implementation and utilization of all quality systems as defined by Shire Procedures.
Support the Compliance to cGxP’s and Shire Procedures keeping partnership between Quality and Operations (engineering, maintenance, manufacturing, automation,…
ESSENTIAL DUTIES AND RESPONSIBILITIES
Represent the quality function in the approval and closing of deviations :
Act as Quality Representative in the evaluation (risk evaluation, lots potentially impacted and to be hold from release), the investigation (including quality impact) and the approval of Deviation Reports.
Supports timely closure of Deviation Reports according to applicable procedures.
Assists, review and approval of Deviation Reports to ensure adherence to quality systems.
Participate in the CAPA process investigation if necessary.
Represent the quality function in the approval and closing of Change Control :
Act as a Quality Representative to review, approve and timely close Change Request according to applicable procedures.
Act as a Quality Representative to review and approve maintenance corrective interventions (WO).
Participate to risk analysis if necessary
Represent the quality function in the approval of Document Change Request.
Routine Requalification: Assure the correct implementation of the shutdown actions by developing test case report according to Shire procedure and associated form.
Act as a quality link on the floor to support adequate quality systems deployment and application.
Support any quality decision in coordination with Manufacturing, engineering, maintenance, automation. Provide support and expertise in all quality related issues.
Perform GMP walkthroughs during routine operations to ensure the application of the cGxP’s, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations. Summarize the walkthroughs in a report.
Participate to continuous improvement projects
Provide support for external audits
Industrial Engineer in chemistry, Biochemistry, Biotechnology, or equivalent with experience
2 - 3 years with general overview of Quality Systems
Have the necessary interpersonal skills to work actively with colleagues in different department
Particular knowledge required:
Technical knowledges related to the manufacturing equipment.
Basic knowledges of industrial automation
Basic knowledges of environmental monitoring
Good level of reading/writing English
Intergrity and trust
Accountability and Integrity
Dedication to Quality
Respect and Inclusion
Critical thinking and problem Solving
Collaboration and Teamwork
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.