Senior GMP Specialist

Randstad
4000.00 - 6000.00
32-40 uren
Bachelor degree

Opdrachtgever

Our client is an ambitious C(D)MO and acts as center of excellence for clients specializing in GMP Manufacturing, process development and cell and gene therapies.

functie Vereisten

MSc in Biotechnology, Chemistry, Biopharmaceutics or equivalent.
Proficiency in cGMPs, GDPs and regulations promulgated by the EMA or equivalent regulatory Agencies.
Eight years of recent experience in (bio)pharmaceutical environment with at least five years of recent experience in Quality Assurance.
Experience within a sterile manufacturing environment, preferable ATMPs (biologicals, vaccines, injectables, parenteral).
Good communication skills in English (in writing and verbally).
Willingness to travel: occasional travelling will be required to support the auditing program.

Wat krijg je?

Pension entitlement as from day one
Collective WGA / WIA insurance
NBBU / ABU collective labor agreement
25 holidays days
8,33% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance

Werkzaamheden

Ensure that the GMP activities and Pharmaceutical Quality system are compliant with the applicable legislation, guidelines and/or quality expectations.
Advise employees, contractors and clients on QA related matters.
Support effective implementation, monitoring, reporting, maintenance and administration of the quality management system.
Ensure effective and timely handling of quality issues (deviations, complaints) and monitor the application and efficiency of corrective and preventive actions CAPA).
Support creation of SOPs, policies and other QA related documentation (writing, review, approval) in alignment with applicable GxP guidelines.
Support (review and approval) of Risk Assessments, qualification/validation protocols and reports to ensure compliance with applicable guidelines and procedures.
Assist compilation of documentation for QP disposition.
Represent QA department in projects.
Participate in the Supplier Qualification process.
Support the organization, hosting and reporting of inspections and audits and coordination of related CAPAs.
Conduct internal audits, and inspections at suppliers and third parties to whom GMP activities are outsourced; qualification and monitoring of those suppliers and third parties.
Act as back-up during Head of Quality absence.