QC Compliance Support Specialist

Posted 25 July 2022
Salary Negotiable
LocationEngland
DisciplineLife Science
ReferenceTR/056130_1658761007
Contact NameVictoria Armitstead

Job description

We at Orion Group are currently recruiting a QC Compliance Support Specialist on behalf of one of our Multinational Pharmaceutical Clients in Liverpool to work on an inital 5-month contract.

Supports the QC Compliance and Improvement Manager in providing compliance support across QC activities.

  • Work closely with the labs to lead Deviations, CAPA's and Change Controls through to on time completion
  • Participate in lab improvement projects
  • To ensure appropriate standards of cGMP, Housekeeping, Health, Safety and Environment are applied in all activities, in accordance with current regulations and procedures
  • Ensure QC compliance with Company Policies
  • Support QC labs with respect to sample delivery from across the Liverpool sites to the labs in a timely manner
  • Keep oversight of and facilitate on time completion of DR's, CAPA's, Change Controls and SOP Updates
  • Monthly and annual report writing for EM, Bioburdens and Endotoxin results, including annual product review.

Responsibilities

  • Supports the QC Managers to ensure QC planning and resources are aligned to the project and supply chain forecasts.
  • Contributes to innovations and improvement projects across QC. To participate in site improvement projects, where required, to drive quality decisions and to provide advice and technical support when required.
  • To ensure the timely completion of DR's and CAPA's and progression of Change Controls to support the QC laboratories. To ensure SOP updates are completed when required for either continual improvement or when due for periodic review.
  • To ensure QC critical KPI's, HSE and cGMP activities are tracked, trended and displayed consistently across QC.
  • Ensure compliance with Company Policies.
  • To ensure timely completion of technical reports.
  • To control and coordinate sample collection from the manufacturing and warehouse areas to the QC labs.

Knowledge, Skills and Experience

  • cGMP background in the Pharmaceutical industry
  • Knowledge and understanding of Lean Lab principles
  • Good understanding of the QC labs
  • Knowledge of continuous improvement techniques and advanced root cause analysis techniques
  • Report writing skills
  • Proven time management skills
  • Proven communication skills both written and verbal
  • Experience of Quality Control / Microbiological testing techniques and industry practices
  • Academically trained to a minimum of degree standard in a relevant scientific discipline

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.