General Duties and responsibilities

• to certify or to confirm, before release for sale or distribution, that everyone finished medicinal product batch has been manufactured and controlled in accordance with GMP, the Marketing Authorization (MA) and applicable EU and Dutch National laws in force.
  For product manufactured and imported from outside the EU, unless an MRA or similar agreement is in place between the EU and the exporting country, to ensure that the finished medicinal product batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal product is in accordance with the requirements of the MA.
• to ensure the QP certification is authorised by the terms of the MIA and to perform QP certification conforming to Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release
• to evaluate the potential impact of a deviation on quality, safety or efficacy of the batch concerned and conclude this impact to be negligible.
  Any impact on GMP compliance and/or MA compliance should be considered.
  When applicable to participate in the investigation on deviations, OOS/OOT.
• to record the QP certification (release to the market or export) of a medicinal product batch in a register or equivalent document provided for that purpose
• to approve shipment under quarantine of uncertified finished product batches
• to ensure that uncertified batches are not transferred to saleable stock
• to approve any subcontracted activities which may impact on GMP and to review, approve and sign of quality agreements for the subcontracted activities concerned
• to ensure and/or to support that self-inspections and audits of subcontracted GMP activities are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place and to participate in self-inspections and audits when required.
• to review, approve and sign of change controls, process validation protocols/reports, analytical transfer activities, SOP’s, APQR’s annual reports
• to participate in the execution of risk assessments, audits and Inspections
• to draft, review, approve and sign QP Declarations as required for regulatory purposes
• to keep appropriate records of any delegated duties
• to decide on the final disposition of rejected, returned, recalled or falsified products and to approve any returns to saleable stock
• to ensure and/or to support that relevant customer GMP related complaints are dealt with effectively and to participate in investigation on critical complaints
• to ensure and/or to support that GMP aspects and the role of the Qualified Person are implemented and maintained in the quality management system and initial and continuous training of personnel
• to inform the management on deviations of GMP compliance and authorised activities as stated on the MIA
• to coordinate and promptly perform any recall operations for medicinal products as requested by the product’s Marketing Authorisation holder
• to ensure that any additional requirements imposed on certain products by national law(s) are adhered to for instance the National Opium Act (Opiumwet)

PPS specific Duties and Responsibilities

• Assure product, process and facilities comply with national and global regulatory requirements in alignment to the Morpeth site policies
• To actively participate in PPS Morpeth Site Quality Review Team Meetings
• Provide support for customer visits and audits

PPS specific Critical Tasks

• Provide QP support to the PPL EU Importation team
• Provide advice, guidance and support to project teams and customers regarding PPL compliance and the requirement of the Dutch Health Authorities.
• Participate as a member of the PPS Morpeth site Quality Management Review Team
• Champion Quality Agenda

Qualifications

Legal Requirements according to directive 2001/83/EC Article 48 as amended from time to time
• The qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Dutch Health Authority (IGJ), extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines:
pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. In the Netherlands a QP is normally a pharmacist.
• The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.
The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.
• The qualified person should be accepted by the competent authorities in the Netherlands and subsequently be listed as such on the Manufacture and Import Authorisation “Fabrikanten vergunning”.

Key Skills
• Robust technical knowledge of EU GMP, regulations and guidelines. Experienced in the operation of an EU regulatory approved QMS.
• Highly collaborative, regular interaction with senior management, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers and regulators.
• Ability to work independently with limited supervision, self-driven, responsive and results orientated.
• GMP auditing knowledge and practical skills, both hosting and performing.
• Good team player, positive attitude and the ability to be flexible.
• Ability to work under pressure in a fast-moving work environment.

Other Qualification Requirements
• Eligible to act as a Qualified Person (QP) under EC/2001/83 Directive as updated.
• Experience acting as a certifying QP for solid unit dose products.
• Experience acting as a certifying QP for IMPs.
• Some experience within quality assurance for sterile products.
• Some experience within quality assurance for narcotic products.
• Minimum C1-level in Dutch and in English.

Working Conditions
• Office based working environment with working from home flexibility.
• Some travel for audits mainly in the EU, but occasional globally.
• The position will report into the Lead QP (NL).