Role Purpose:

  • An exciting new vacancy has arisen for a QC Stability Specialist to join our client’s busy biopharmaceutical facility in Co. Waterford.
  • The QC Stability Specialist will be responsible of the management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders.
  • The role requires to be on site 5 days a week (potential for 1 day working from home after training period is passed to the managers satisfaction).

 

Core Duties and Responsibilities:

  • Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs).
  • Raising and on time closure of Stability, PQR and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
  • Procedure effectiveness and simplification and actively contribute to continuous improvement initiative utilising lean methodologies where appropriate.
  • Ensure effective co-ordination and support for external and internal audits for the department.
  • Perform critical / constructive review of Stability, PQR and trending related procedures and practices.
  • Identify and lead projects to make step change improvements to the department’s Quality.
  • Conduct duties in a safe manner and report all safety issues or concerns Support leadership team in achieving goals/ tasks Liaise with Quality assurance Representative to support and improve RFT in the area and Always Audit Ready.
  • Ensure all required training is completed on time.
  • Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).

 

Education & Qualifications Required:

  • Degree in Science or Chemistry
  • Minimum 4-5 years experience within a stability role in a GMP environment required.

Please note, we do not require agency assistance with this role.


Apply Now

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Role Details:

Job Title: QC Stability Specialist
Location: Waterford
Type: Contract
Date: June, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: QC Stability Specialist
Location: Waterford
Type: Contract
Date: June, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • An exciting new vacancy has arisen for a QC Stability Specialist to join our client’s busy biopharmaceutical facility in Co. Waterford.
  • The QC Stability Specialist will be responsible of the management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders.
  • The role requires to be on site 5 days a week (potential for 1 day working from home after training period is passed to the managers satisfaction).

 

Core Duties and Responsibilities:

  • Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs).
  • Raising and on time closure of Stability, PQR and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
  • Procedure effectiveness and simplification and actively contribute to continuous improvement initiative utilising lean methodologies where appropriate.
  • Ensure effective co-ordination and support for external and internal audits for the department.
  • Perform critical / constructive review of Stability, PQR and trending related procedures and practices.
  • Identify and lead projects to make step change improvements to the department’s Quality.
  • Conduct duties in a safe manner and report all safety issues or concerns Support leadership team in achieving goals/ tasks Liaise with Quality assurance Representative to support and improve RFT in the area and Always Audit Ready.
  • Ensure all required training is completed on time.
  • Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).

 

Education & Qualifications Required:

  • Degree in Science or Chemistry
  • Minimum 4-5 years experience within a stability role in a GMP environment required.

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
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