Quality Specialist

2 weeks ago

Dublin, Dublin City, Ireland Besins Healthcare Full time

Direct message the job poster from Besins Healthcare

Recruitment Officer at Besins Healthcare

About Us

We are a pioneering, family-owned pharmaceutical company dedicated to advancing the development and global commercialization of reproductive hormone therapies that support the lifelong health and well-being of both men and women.

Our products are widely used in gynaecology, fertility, obstetrics, and endocrinology. With a presence in over 90 countries through a strong network of subsidiaries and distributors, we continue to grow sustainably. Today, we operate with approximately 1,600 employees, 22 subsidiaries, and 5 manufacturing sites. Our continued success is built on attracting exceptional talent and fostering a collaborative, growth-focused environment.

Purpose of the job:

The main purpose of this position is management of the Quality System functions in the organisation in relation to the following main systems focus (not limited to): Deviations and CAPAs. This role will also support with the following systems: Documentation, Change Controls and Training with an overall aspect of risk management process activities incorporated therein. This job will involve working on a manual and electronic Quality Management System including aspects of an electronic system administration activities. This is a corporate cross functional role that will cover working in the global organisation covering a variety of products.

Key Responsabilities :

Deviations

Act as a deviations process owner to support organisation to manage deviations accordingly.
Facilitating cross functional meetings and providing guidance and consultation to deviation stakeholders.
Collaborating with other departments on completion of investigations and root cause analysis.
Supporting in establishment and implementation of effective corrective/preventative actions.
Ensure completion of Effectiveness checks.
Work on harmonization of processes related to deviations across the organisation.
Identify and drive improvements/updates to the Deviations system.
Prepare, support and maintain applicable KPIs.
Assisting as needed in audits and inspections

CAPAs

Act as a CAPA process owner to support organisation to manage CAPA accordingly.
Management of CAPAs that derive from various processes: deviations, internal audits etc.
Facilitating cross functional meetings and providing guidance and consultation to CAPA owners.
Collaborating with other departments on completion of CAPAs
Supporting in establishment and implementation of effective corrective/preventative actions.
Ensure completion of Effectiveness checks.
Work on harmonization of processes related to CAPAs across the organisation.
Identify and drive improvements/updates to the CAPAs system.
Prepare, support and maintain applicable KPIs.
Assisting as needed in audits and inspections

eQMS Administration - Deviations and CAPAs

Support administration aspects of Deviations and CAPAs management via eQMS
Work with IT department to support validation activities of the eQMS, where required.
Work with IT department to maintain validated state of the eQMS.
Integration of eQMS Deviations and CAPAs in an organisation via building eQMS community.
Act as Quality Subject Matter Expert (SME) for eQMS Deviations and CAPAs
Deliver eQMS Deviations and CAPAs related trainings.
Assisting as needed in audits and inspections

Audits and Inspections

Perform Internal Audits when required.
Act as a SME regarding Deviations and CAPA process for a preparation of audits and inspections.
Attend Audits and Inspections where required.

Other

Flexibility in supporting other relevant QMS activities when required.
Become a Quality role model and an ambassador for a Quality mission in the organisation

Job Requirements:

Pharmacist or Engineer with Master's degree in quality, Regulatory or scientific topic
A minimum of 2 + years of experience in pharmaceutical or biotechnology industries
Relevant experience in either quality, regulatory, manufacturing, or development.
Understanding of GxPs, quality systems and regulations (EU, FDA, ICH).
Proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and SharePoint required.
Experience with Quality Management Systems heavily preferred
Ability to perform independent work requiring attention to detail, accuracy and scientific judgment and a consistent record of shifting thought processes quickly from one task to another.
Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports and regulations to make decisions in GXP environment
Experience in project management and ability to develop effective working relationships with internal/external sites and crossfunctional project teams.
A proven track record of establishing and maintaining effective working relationships with managers and employees as well as influencing individuals of various levels to gain understanding and/or acceptance of an idea, policy, procedure, or plan.
Excellent interpersonal, written and oral communication skills with the ability to utilize active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships
Ability to work in an international matrix environment.
Fluent English skills required, French or other languages will be a plus.

Seniority level

Seniority levelAssociate

Employment type

Employment typeFull-time

Job function

Job functionManufacturing
IndustriesPharmaceutical Manufacturing

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