Quality Specialist Benelux

仕事内容

We are looking for a Quality Specialist Beneluxfor one of our clients in the pharmaceutical sector based in Anderlecht.

Don’t hesitate to contact me : delphine.vanriet@professionals.randstad.be - Life Sciences Wallonia.

This is a contract as Consultant (employee or freelance): Project starting in June 2024 until 31/12/2024

Embark on an exceptional adventure with a global biopharmaceutical company, driven by an unwavering passion to meet the crucial needs of people affected by serious diseases.

The goal of this function of Quality Specialist Benelux, is as follows:

• To ensure global quality practices are integrated in the affiliate to ensure compliance is met with regard to our customer’s local regulations.
• To maintain the GDP/GMP status of the affiliate in accordance with national and international GDP, GMP and legal requirements.
• To ensure QA deliverables are achieved in a compliant timely manner.
• To support the Benelux affiliate Quality in the ordinary and extraordinary tasks.

As Quality Specialist Benelux,here are the tasks you’ll do:

• Product Complaint Management – Receipt of PQC from customers/ customer Cares,opening in eQMS, discussions with CCU and the complainant, organizing return sample shipments, replacement product to customer. Reporting outcome to the complainant.
• Batch administrative GDP release - Full process of reviewing 3PL inbound documentation, transport temperature data, decide on GDP release to saleable stock.Release related communications with 3PL. Managing documentation approval and archiving in Source CD.
• Administrative release of rework activities – Reviewing of 3PL batch documentation of local review, decide on GDP release to saleable stock. Rework relatedcommunications with 3PL. Managing documentation approval and archiving in Source CD.
• Deviation Management, when Deviation originates in the processes covered by Quality Specialist, or when separately agreed. Typically opening and follow-up of primary transport deviations (shipment from global site to local 3PL) in eQMS, facilitating investigations by Global distribution Quality or other stakeholders.
• Document and Record Management; Ensure archiving of documents in correct systems (TW, Source CD, Source Quality) for the processes Quality Specialist manages.
• Staff Qualification (ensuring Quality Specialist completes assigned trainings in a timely manner)
• CAPA Management, as requested.
• Change Control Management, supporting local change control processes as requested.
• Vendor Management; Contact person to local 3PL, as agreed. Daily contact to 3PL for different distribution related questions including decision taking in case of temperature excursions.
• Customer qualification; Checking Dutch customer’s documentation to verify eligibility to order, manage related approval and documentation in Source CD, as requested.
• Internal and External Audit Management, supporting local audits and inspections andrelated CAPA work, as requested.
• Recall Management, supporting local recalls and mock-recall, as requested.
• Narcotics management, local administrative activities, as requested.

As Quality Specialist Benelux, we expect the below competencies:

• Master’s Degree or Bachelor’s degree
• Ability to effectively interact with and influence internal personnel on productand quality related matters with a customer-oriented mindset.
• Has a detailed, accurate way of working.
• Ability to manage complex administrative tasks and manage own work.
• Ability to analyze data and information to draw conclusions and make effective decisions and escalate as required.
• Self-motivated team player, who can support new ideas.
• Possesses root cause and risk management/assessment skills as needed.
• Fluent and confident use of local (Dutch and/or French) and English language verbally and in reading & writing.

For this position of Quality Specialist Benelux, we offer an attractive salary with below benefits:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate as a freelancer is also possible.