Qualified Person

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Requisition ID: 68392

Date: Jan 13, 2025

Location: Dublin, Leinster, IE

Department: Quality

Description:

At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary:

The Qualified Person (QP) will have responsibility for making disposition decisions in relation to human medicinal products and Investigational Medicinal Products (IMP) that are assembled at West, released and shipped to the customer (the Marketing Authorisation Holder (MAH), for further processing. This disposition activity represents QP confirmation of partially manufactured Human Medicinal Products. Human Medicinal Products that are assembled, labelled and secondary packaged at Tech Group Europe Limited (t/a WEST) will be required to be batch certified by the West QP as the EU site of batch release. In addition, the QP will guide and support the Quality Team at West on all aspects of pharmaceutical regulatory compliance. Report directly to the Director, Quality.

Essential Duties and Responsibilities:

The Qualified Person will ensure the following:

• For medicinal products manufactured within the European Community that each batch has been produced and tested/checked in accordance with the relevant EU Directives and the Marketing Authorisation.
• For medicinal products manufactured outside the European Community ensure that each imported batch has undergone, in the importing country, the testing specified in paragraph 1 (b) of Article 51.
• Certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51.
• To ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation and the principles and guidelines of EU Good Manufacturing Practice.
• Shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities.
• Before dispositioning a batch, the QP doing so should ensure, that at least the following requirements have been met:
• The batch and its manufacture comply with the provisions of the Marketing Authorisation (including the authorisation required for importation where relevant).
• Manufacture has been carried out in accordance with Good Manufacturing Practice or, in the case of a batch imported from a third country, in accordance with Good Manufacturing Practice standards at least equivalent to EC GMP.
• The principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
• Any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
• All the necessary checks and tests have been performed, including any additional sampling, inspection, tests, or checks initiated because of deviations or planned changes.
• All necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
• All audits have been carried out as required by the quality assurance system.
• Should in addition take into account any other factors of which he/she is aware which are relevant to the quality of the batch.
• Ensures the QC/QA checklist and QP Disposition statements meet all regulatory requirements and includes any updates to regulatory requirements where applicable (e.g. Annex 1 contamination control strategy requirements).
• Comply with the duties and responsibilities defined in EU Directives 2001/83/EC and 2003/94/EC and Eudralex Volume 4 Annex 16: Certification by a Qualified Person and Batch Release and contained in a separate technical agreement.
• Have responsibility for making a release decision in relation to medicinal products assembled at West. This decision will be based on a detailed review of batch files and a detailed knowledge of the quality management system and of manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Have responsibility to batch certify human medicinal products assembled, labelled and packaged at West. This decision will be based on a detailed review of West batch files and batch files from the site of drug product manufacture (where applicable) and a detailed knowledge of the quality management system and of the manufacturing and testing processes at West. The release decision will also be based on a risk assessment of any deviations, out of specification investigations etc. associated with the batch.
• Ensure the QMS in place at West to support West as a site of batch release meets all GMP and regulatory requirements for batch certification including supply chain mapping, risk assessments and supplier approval processes.
• Review documentation and release certificates for QP confirmation provided by the QP at the MAH/manufacturer of the medicinal product which is to be assembled into the drug delivery device at West.
• Where West perform assembly of Human Medicinal Product only, release the product to the next stage of processing. The responsibility for subsequent manufacturing operations and release to market will lie with the QP at the MAH.
• Provide advice on regulatory compliance in relation to the Quality Management System, deviations or other anomalies which could impact on the safety and compliance of medicinal products, validation requirements and on other technical matters, as requested.
• Communicate with the customer, MAH, HPRA and other regulatory authorities, as necessary.
• Assist with preparation for regulatory inspections, participate during inspections, agree responses to regulators and advise and follow up on corrective and preventive actions until close out.
• Remain well-informed on regulatory updates for example by attending the annual QP forum, interpreting regulatory drafts or submission to understand impact on West operations.
• Remain informed about performance of the QMS and emerging quality trends and risks such as complaints, audit findings, deviations, non-conformances etc.
• Ensure attendance at West's quarterly review and West's management review as it relates to medicinal product.
• Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties as assigned.

Basic Qualifications:

• Meet the requirements of EU Directive 2001/83/EC Article 49 as amended and EU GMP including IMP requirements.
• Hold a 4-year degree programme in pharmacy, chemistry, biology, microbiology or equivalent.
• Hold a HPRA - recognized postgraduate qualification from an approved university course to act as Qualified Person, such as the Graduate Diploma in Pharmaceutical Manufacturing Technology at Trinity College, RCSI or UCC, where the primary degree is not Pharmacy.
• Not have any previous or pending legal or disciplinary actions in relation to QP work.
• Declare any conflicts of interest.

Preferred Knowledge, Skills and Abilities:

The QP ideally should have:

• Been named previously on a medicinal manufacturing licence issued by the HPRA and have experience in dealing with the HPRA.
• At least 5 years' experience working in Quality at a pharmaceutical manufacturer; experience of medical devices is also desirable but not essential.
• Knowledge of and experience in setting up and maintaining a QMS which meets the legislative requirement of human medicines in the EU and USA.
• An understanding of the regulatory requirements for combination products with medicinal and device components.
• Experience and good judgement in product safety management and quality risk management.
• Experience of hosting regulatory inspections from either the European or US authorities.
• The ability to organise and prioritise tasks, be detail oriented and self-motivated.
• Excellent written and verbal communication skills.
• Be flexible in terms of availability to West as and when required.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company's safety policy at all times.
• Able to comply with the company's quality policy at all times.

Travel Requirements:

• Not applicable to this role.

Physical & Mental Requirements:

• Use written and oral communication skills.
• Read and interpret data, information and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

Delegation of Duties:

When absent from the site, duties and responsibilities will be delegated to the following designates:

• May designate duties to named QP as per West's current Manufacturer's Authorisation and IMP Authorisation where applicable.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.