Sharp is a global leader in pharmaceutical packaging with locations in the US UK Netherlands and Belgium. Our Heerenveen site specializes in commercial labeling packaging and clinical support services.

At Sharp Heerenveen youll join a growing international team of 80 professionals dedicated to enhancing patients quality of life. Our Dutch facility offers 3500 m² of GMP-compliant packaging space and extensive expertise in packaging design serialization QP market release and artwork services. We prioritize our customers delivering flexible tailored solutions to meet their complex needs.

To strengthen our team we are recruiting for a:

Qualified Person
Heerenveen

The Qualified Person is responsible for ensuring that at Sharp produced products are confirmed to be in line with cGMP (release to customer). Additionally the Qualified Person at Sharp can be responsible for ensuring that Clinical trial products are certified for distribution to the clinical trial locations and that commercial products are certified for the market. You will also certify supply chains for manufacturing and testing and can act as co of lead auditor during external and internal audits. You communicate with colleagues worldwide and with external parties. As a Qualified Person you will support the department in continuous improvement activities

Position

• Certify supply chains for IMPs by assessing related CMOs to be able to provide QP declarations.
• Certifying batches for release to clinical trial locations or supply (in compliance with EU and international regulations).
• From a clinical point of view driving site GDP/GCP/GMP compliance and providing QP guidance to the site and training and development in GDP/GCP/GMP and related issues.
• Familiarizes with new pharmaceutical manufacturing technologies and Advanced Therapy Medicinal Products.
• Act as a QP to ensure that each batch of commercial medicinal product has been manufactured and checked in compliance with the laws in and in accordance with the requirements of the marketing authorization.
• Decide on batch disposition of materials and final finished product in line with Annex 16 to the EU Guide to Good Manufacturing Practice Title: Certification by a Qualified Person and Batch Release and Article 48 of Directive 2001/83/EC and Article 52 of Directive 2001/82/EC.
• Oversee the Quality system to fulfil the Batch Disposition task as mentioned in previous bullet point.
• Participate in the enhancement of the Sharp quality system to assure the right cGMP level for the process and systems at Sharp NL
• Participate in projects and contribute to: project execution validation activities and strategy compliance to existing legislation or customer requirements and correct implementation of the project in the production environment.
• Participate in projects and be responsible for the approval of validation documentation up to PV protocol.
• Report progress on projects and related validation activities in weekly meetings with delegate QPs and QA Lead/QP.

The QP has joined responsibilities with QA for:

• Customer complaints
• Deviations
• Supplier complaints
• CAPA
• Change control
• Supplier and internal auditing
• Regulatory and customer auditing
• Generating KPIs
• Provide training to other employees by demonstration repetition modelling large group training etc.
• Assist in controlling the correct working of the quality management system. Oversee the quality system evaluation and approval of Change requests CAPA plans and outcome of quality reviews
• Batch documentation integrity by means of batch record review review of analytical records and other relevant batch information.
• Key support role in client and authority audits of Sharp.

Profile

• Master level Pharmacy degree qualification or something similar
• Approved QP status and eligibility for the QP role
• Completed with relevant training and courses; evidence of Continuous professional development desirable
• A first experience in a QP role for pharmaceutical manufacturing is highly desirable
• Active in depth knowledge on current Good Manufacturing Practices
• Good knowledge of Eudralex guidelines and pharmaceutical regulations.
• Knowledge on Medical Device regulations is desirable
• High level of spoken and written English
• Ownership
• Team player able to work with all levels in the organization
• High level of integrity
• Think in processes
• Positive mind set / Think in solutions

Offer

At Sharp we strive to create a work environment where all employees can maximize their potential. We offer a versatile and challenging position in a dynamic workplace with numerous career development opportunities. You can expect a suitable salary package supplemented with a range of benefits such as:

• A full-time position with diverse responsibilities
• Travel allowance starting from 10 km
• Work-from-home allowance
• Internet allowance for remote work
• Bike leasing option
• Pension plan

Type of contract: Regular

Time schedule: full-time

Regime: day shift

Interested Apply with resume and cover letter Contact: Larissa Piebenga Neptunus 12 8448 CN Heerenveen

Sharp will not accept unsolicited assistance from recruitment agencies for this vacancy. CVs sent to Sharp by recruitment agencies without specific instructions from the HR department will be considered the property of Sharp. Unfortunately we cannot pay compensation in that case even if the candidate joins Sharp through this referral or other means. We kindly request that you do not reproduce this vacancy in whole or in part without permission.