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Business: PCC
Department: QualityLocation: NetherlandsTravel: 4 days a week in office, 1 day a week from home (minimum is 3 days a week in office)
Job Overview
The primary legal responsibility of the Qualified Person is to certify batches of Medicinal Product
prior to release for sale and placing on the market (Human and Veterinary Medicinal Products) or prior to use in a Clinical Trial (Human Medicinal Products only).The Qualified Person in alliance with key personnel (e.g. heads of production, quality control, quality assurance and supply chain) should also ensure that the manufacturer/importer is able to demonstrate that his authorised operations are being performed in compliance with EU-GMP (Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use) and relevant articles of other applicable EU-directives amongst which 2001/83/EC, as amended and 2011/62/EU (Falsified Medicines Directive) and the applicable Dutch National Legislations The Medicines Act (Geneesmiddelenwet) and Opium Act (Opiumwet) and that public service obligations are met.The Qualified Person is responsible for the direct supervision of the company and is expected to be regularly present at the facilities where the activities take place in order to overview the organisation and all activities to ensure compliance with the legal requirements at any time.The Qualified Person, as a designated person (2001/83/EC; article 48), should fulfil his/her responsibilities personally and should be continuously contactable.The Qualified Person may delegate duties but not responsibilities.The manufacturer/importer should give the Qualified Person the defined authority, resources and responsibility needed to fulfil their duties.The Qualified Person should be listed on the companies Manufacture and Import Authorisation (MIA).
Reporting Structure
Direct executive to report to: General Manager / Lead Qualified Person.
Acting Representative during absence: Qualified Person
Experience
- 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.
Competencies
- 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 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)
Qualifications
- Eligible to act as a Qualified Person (QP) under EC/2001/83 Directive as updated.
- Experience acting as a certifying QP for sterile products and solid unit dose products.
- Some experience within quality assurance for narcotic products.
- Minimum C1-level in Dutch and in English.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.
PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.Job Info
- Job Identification 8881
- Job Category Quality
- Posting Date 06/24/2025, 05:15 PM
- Job Schedule Full time
- Locations Piramal Critical Care, Haarlem, Haarlem, 2023 GE, NL
