Job description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Description:

Role Title: Quality Executive

Role Purpose:

• The QE is responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC/Cluster (including controlled substance requirements and all named-patient materials NPP).

• He/she is also responsible for compliance with the elements of the *** Quality Policy and *** QMS that are applicable to the GMP/GDP activities the LOC/Cluster undertakes. This position is also responsible for the continuous improvement of the GMP/GDP status of the LOC/Cluster.

• He/she is responsible for the oversight of quality and compliance status of all third parties and other *** organisations engaged by the LOC/Cluster for the GMP/GDP activities for the LOC/Cluster.

Not Expected to:

• Act as Responsible Person (GDP) or Qualified Person (GMP).

• Make final decision on product recall.

Key Role Activities:

Implement, maintain and monitor the GMP/GDP part of the *** quality system for the commercial organisation in the LOC (to include but not restricted to):

• Ensure that a list of all relevant product sourcing, supply routes (including exports), product licences (marketing authorizations), product list, relevant authorizations, (e.g. manufacturing, packaging, importation, warehousing, distribution, testing, narcotics handling, etc.) and quality agreements is available and maintained up to date for the Irish market.

• Execute requirements regarding lifecycle management of GMP/GDP related documents and records (creation, approval, distribution, revision, retrieval, retention, disposition) to ensure regulatory compliance and business continuity. Including the preparation, update and approval of procedures assigned.

• Ensure the provision of appropriate training for all regulated functions with GMP/GDP responsibilities.

• Ensure appropriate management of internal and external Change Controls related to the Irish market.

• Oversee the preparation, execution and follow up for corporate and external Irish inspections, and report these and any other relevant field action activity into the relevant systems.

• Ensure appropriate management of the preparation, execution and follow up of internal and external Quality Issues (QIs) and CAPAs related to GxP in Ireland.

• Monitor Quality System performance versus local GxP and *** requirements via use of pertinent business and compliance metrics and goals.

• Provide the necessary input to the Quality Head for the bi-annual Quality System Management Review for the LOC/Cluster. Co-ordinate the timely preparation of the QSMR presentation i.e. slide deck by gathering input from all SMEs and stakeholders.

• Notify and engage LOC Quality Head and Business Quality Regional and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures. The QE supports the local Quality Head for escalations of the LOC/Cluster where needed.

Quality processes (to include but not restricted to):

• Artwork support: labelling changes oversight via Control of Change process.

• Conduct regular (self-)inspections of GxP practices that are applicable on the supply chain within the responsibilities of the Local Operating Company.

• Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, Deliver QA, ASM, Regulatory Affairs, Medical Affairs, Medical Compliance, other Cluster / LOC in EMEA and any other functions.

• Ensure GxP Irish suppliers in the LOC/Cluster are qualified, are periodically audited against company & local GxP standards, if relevant and, when needed, have a quality agreement. Timely preparation of quality agreements. Perform supplier audits as required.

• Support the LOC management team in new product introduction in Ireland and all other product portfolio lifecycle management processes.

• Support the QH in escalating quality issues and conducting recalls in Ireland in a timely manner.

• Perform Product Quality Reviews for products marketed in Ireland, reviewing local PQRs.

• Ensure that any requirements of the Wholesale Dealers Licence are fulfilled.

• Work closely with the sites and Deliver QA to ensure that Temperature Control requirements are fulfilled during storage and transportation activities.

• Assure effective processes to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner.

• Perform the QA approval of repackaging jobs of Irish products and ensure that all required aspects of GMP are followed at both the repackaging site and within the company for these jobs.

Role Dimensions:

• Communication with others outside **** e.g. suppliers, governing bodies, the general public

• Contract Manufacturers/Suppliers – high importance, frequent

• General public, healthcare professionals, wholesalers - high importance, frequently

• HPRA – high importance occasionally

• Trading Standards – medium importance very infrequent

Communication with others within *** :

• Market Research, Commercial, Medical Affairs, Medical Compliance, BQ EMEA, JJRC, *** Consumer and *** MDD – supplier engagement. These are important to support the business activities and projects in a timely manner.

• Drug Safety, Medical Information, Customer Services, Supply Chain, Regulatory Affairs, ASM, - specific quality issues as they arise. These are important as they can relate to customer care, compliance issues, potential out-of-stock situations and/or audits and inspections findings.

• *** sites of manufacture and Deliver (global) – regarding quality issues. These are important as they relate to the timely processing and timely resolution of quality problems.

​

Requirements

Essential Technical Knowledge, skills and experience:

• Fluency in the national language(s) and the English language is required.

• External Body Qualification/Certification as Internal Auditor is preferred title.

• Quality Assurance experience at operational level or other relevant experience including Quality Compliance.

• Direct experience and sound knowledge of general quality requirements and guidelines/legislation.

• Leadership and Teamworking capabilities.

Qualifications:

The QE should meet the following knowledge, experience and skills:

• primary degree in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;

• at least 2 (ideally 5) years’ experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution, Warehouse management. Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential;

• understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes;

• up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners;

• knowledge and full understanding of the *** Quality Policy and Standards, the Cluster / LOC QMS and Deliver QMS.

• Business acumen to balance safety, compliance and availability of product for a patient.

• Team player within region, ability to leverage across LOC’s in EMEA / WW.

• Open for standardization: regional and local thinking, team player at EMEA level.

#LI-DM1

Job Type: Full-time

Salary: €27,226.93-€55,677.64 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Dublin, County Dublin: reliably commute or plan to relocate before starting work (required)

Reference ID: 11905

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