Qualified Person / Deputy Qualified Person for Pharmacovigilance
Functie omschrijving voor de functie Qualified Person / Deputy Qualified Person for Pharmacovigilance
Certification that each batch of medicinal products has been manufactured and checked in compliance with the EU GMP requirements, the laws in force in the respective EU Member State and in accordance with the requirements of the marketing authorisation;
Certification is permitted under the terms of the MIA.
Any additional duties and requirements of national legislation are complied with.
Certification is recorded in a register or equivalent document.
Ensure and demonstrate they have detailed knowledge of the steps for which they are taking responsibility. The QPs should be able to prove their continuous training regarding the product type, production processes, technical advances and changes to GMP.
Supply Chain traceability and compliance Vendor Management Oversight:
Ensure the entire supply chain of the active substance and medicinal product up to the stage of certification is documented and the relevant vendor qualification program is maintained.
Ensure all relevant audits audit reports are available to the QP.
Ensure the active substances have been manufactured in accordance with GMP and, where required, distributed in accordance with Good Distribution Practice (GDP) for Active Substances.
Ensure the excipients have been manufactured in accordance with the ascertained GMP.
Ensure that a written final assessment and approval of third party audit reports have been made. Ensure there is access to the documentation pertaining to the audits.
Quality Issues Oversight:
All investigations pertaining to the batch being certified (including out of specification and out of trend investigations) have been completed to a sufficient level to support certification.
Any on-going complaints, investigations or recalls do not negate the conditions for certification of the batch in question.
QMS Oversight and Product Quality Review:
The QMS is compliant and effective and demonstrate QMS oversight. The required technical agreements are in place.
The self-inspection programme is active and current.
The appropriate arrangements for distribution and shipment are in place. On-going stability data and product quality reviews are in place, adequate and continue to support certification.
The impact of any change to product manufacturing or testing has been evaluated and any additional checks and tests are complete.
Quality Management Review:
Ensure Senior Management is informed on any compliance, regulatory or quality issues in a timely manner.
Participate to Quality Management Review meetings.
Participate to regulatory inspections.
Act as a local QPPV in Netherlands and deputy up QPPV for Pharmacovigilance and provide support as required by the business in the following areas in the absence of the EU QPPV:
1) Ensure the continuous pharmacovigilance contact point for the competent authorities in Member States and the European Medicines Agency (and also as a contact point for pharmacovigilance inspections.
2) Support the Establishment and maintenance of the marketing authorisation holder’s pharmacovigilance system.
3) Ensure and verify the information contained in the PSMF is an accurate and up-to-date reflection of the pharmacovigilance system under the QPPV’s responsibility.
4) Overview of medicinal product safety profiles and any emerging safety concerns;
5) Awareness of any conditions or obligations adopted as part of the marketing authorisations and other commitments relating to safety or the safe use of the products;
6) Review and approve the content of risk management plans and be aware of risk minimisation measures;
7) Ensure awareness, review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a risk management plan agreed in the EU;
8) Ensure quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities in Members States and the Agency;
9) Ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit risk evaluation of a medicinal product.
• 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.
Functie eisen voor de functie Qualified Person / Deputy Qualified Person for Pharmacovigilance
• Eligible to act as a Qualified Person (QP) as updated and eligible to act as a Qualified Person for Pharmacovigilance under EC/2001/83 Directive.
• Experience in sterile and non sterile dosage forms as certifying QP.
• Previous experience as a QPPV is desirable.
• Minimum a BCS degree in life science.
• Minimum 5 years’ experience in a similar Quality Assurance role within the Pharmaceutical Industry.
• Relevant GMP and PV training as required to discharge assigned duties and responsibilities.
• Office based working environment, availability to travel up to 35% of the time.
• The positions will report into the Head of Quality EU (Europe and UK).
Our Pharmaceutical client is a top 3 largest producer of inhaled anesthetics and a global player in hospital generics. ‘Save lives with critical care solutions’ is much more than a purpose statement to us. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe, while achieving sustainable and profitable growth for all the stakeholders. Our client maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Our product portfolio includes inhalation anesthetics, injectable pain and anesthesia drugs, Intrathecal Baclofen therapy for spasticity management, and plasma volume expanders. Our products include Sevoflurane, Isoflurane, Halothane, Gablofen, Polygeline, Alfentanil, Fentanyl, Sufentanil and Etomidate.
Our core strength lies in our highly qualified global workforce..
Competitief, kom in contact voor details.
06 394 333 73