QA Lead Specialist New
QA Lead Specialist
12 months contract position
Location: Swords Campus
ABOUT US?
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 at www.skpharmteco.com
Current Need:
The Quality Team at SK pharmteco Ireland here at the Swords Campus are looking for a QA Lead Specialist on a 12 month contract basis.
Position Description:
The QA Lead Specialist is responsible for managing the site change control process, administration of quality systems and metric management. Providing support to the document management and training systems is required. Candidates must be capable of working on their own initiative and of handling several tasks at a time.This role will report directly to the QA Manager.
Main responsibilities (including but not limited to):
- SME and point of contact for local Change Control procedures and initiatives.
- Co-ordinate the change control endorsement meetings and perform the Change Evaluation activity for change controls on TrackWise.
- Change Control and Effectiveness Review Monthly Metrics.
- Act as Site Administrator for TrackWise QMS and DCA DMS - create/modify/delete user accounts and reset passwords where required.
- Give guidance on system use.
- Escalating any technical issues to the appropriate level via the IM Helpdesk or vendor.
- Prepare information for monthly Quality Council.
- Responsible for Training Coordination within QA.
- Prepare and monitor the procedures necessary to operate the QMS and DMS.
- Manage the relationship with the off-site storage vendor.
- Participate in regular department team meetings.
- Provide cover for the document management system (DCA) functions e.g. document approval, hard copy issuance.
- Ensure completed GMP batch records are filed and archived as per procedures.
- Provide cover for the learning management system (Success Factors) functions e.g. rolling out online training, crediting classroom training.
- Assist with audit preparation and backroom activities.
Manage Information
Use of site documentation management system, deviation/CAPA/CC system and training systems.
Teamwork
Build effective working relationships.
Support a team culture committed to high performance.
Ensure cGMP and safety compliance is adhered to at all times.
Support less experienced members in cross functional teams.
Safety- Demonstrate Safety first principles at all times.
Minimum Requirements:
- Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 5 years pharmaceutical experience ideally in a QA or related role.
- A working knowledge of the EU and US GMP regulations.
- Experience in change control/documentation management, good manufacturing practices within a pharmaceutical operation.
- Well-developed administrative and organisational skills.
- Capable of working on own initiative.
- Good communication, interpersonal skills and presentation skills.
- Good time management and ability to prioritise tasks.
- Strong technical writing ability.
Desired/Advantageous
Experience/skills in:
- TrackWise admin experience a plus.
- Success Factors admin experience a plus.
- Experience in regulatory inspections.