QA Senior Specialist

Cpl Healthcare; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

A global CDMO is seeking a QA Senior Specialist for its Dublin facility. This permanent role requires a BSc in Chemistry and 3 years of QA experience in the pharmaceutical industry. Responsibilities include ensuring adherence to cGMP, reviewing documentation, and supporting continuous improvement initiatives. The role offers competitive salary and benefits like bonuses and private healthcare.

Benefits

Excellent career enhancement opportunities

Competitive base salary

Annual bonus linked to business results

Established further education program

Pension scheme

Private Healthcare

Qualifications

• Minimum 3 years pharmaceutical experience, ideally in a QA role.
• Demonstrates excellent time management and organizational skills.
• Can work on their own initiative and part of a team.
• Exhibits SK pharmteco values and behaviors.

Responsibilities

• Ensure products meet cGMP during manufacturing, storage, and packaging.
• Review and approve batch documentation and cleaning logs.
• Participate in procedure preparation and review.
• Support quality culture and continuous improvement initiatives.

Skills

Time management

Organizational skills

Communication skills

Presentation skills

Ability to multi-task

Education

BSc or BEng in Chemistry or related discipline

Job description

QA Senior Specialist

Permanent

Location:Swords, Co. Dublin, Ireland

About the company?

SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce, exceptional technical capabilities and facilities we have made some of the world’s most important medicines and continue to do so. Further information on SK pharmteco can be found atwww.skpharmteco.com

Current Need:

The Quality Team here at the Swords Campus are looking for a QA Senior Specialist on a permanent contract.

Position Description:

• Working as part of the QA Quality team, site cross functional teams and customer teams to ensure that customer products are manufactured, stored and packaged in accordance with cGMP.
• Review and approval of documentation associated with the manufacture of Commercial and New Investigational Products.
• Review and approval of manufacturing and cleaning batch documentation and associated equipment logbooks in accordance with cGMP.Responsible for the batch disposition of Commercial and New Investigational Products.
• Participate in the preparation and review of procedures and batch documentation including process risk assessments.
• Support the quality culture on site through actively supporting operations on the shop floor.
• Actively contribute to continuous improvement initiatives including lean ways of working and the development and maintenance of metrics, trends and key performance indicators.

Minimum Requirements:

• The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline and should have at least 3 years pharmaceutical experience, ideally in a QA role.
• The successful role holder will be able to demonstrate excellent time management and organizational skills along with a proven ability to multi-task.
• The Quality Assurance Senior Specialist will be required to work on their own initiative as much as working a part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.
• The ideal candidate will lead by example and exhibit SK pharmteco values and behaviors.

Other Benefits include:

• Excellent opportunities for career enhancement and personal development
• Competitive base salary
• Annual bonus linked to business results
• A well-established further education program.
• Pension scheme
• Private Healthcare

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