Interim QA Consultant
- England, South West
- Contract
- Compliance / Quality Assurance
Our client, a speciality pharmaceutical company based in the South of the UK are looking for a Interim QA Consultant. Experts in their field they have a focus on the central nervous systems, gastroenterology, ophthalmology and rare diseases identifying difficult to manufacture therapeutic products and working with trusted partners to get them to the market.
Responsibilities:
- Support the Quality System Manager in managing the structured closure of legacy QMS records.
- Prioritise and execute record closures using a risk-based approach, escalating concerns or high-risk issues as required.
- Migrate selected open or relevant records from the legacy QMS to Veeva Vault Quality QMS modules, ensuring traceability and accuracy.
- Ensure procedural documents are structured, validated, and submitted through correct approval workflows.
- Assist in preparing training materials for new procedures or system changes (e.g., transition to Veeva Vault).
- Timely closure of agreed legacy records and system
- Working collaboratively in cross functional teams
- Degree in Pharmaceutical Sciences, Life Sciences, or related discipline (or equivalent experience).
- Extensive experience in a GMP/GDP-regulated pharmaceutical environment, ideally within a Quality Assurance or Compliance role.
- Proven experience in managing and closing Quality Management System (QMS) records such as Deviations, CAPAs, Change Controls, and Risk Assessments.
- Experience supporting migration from legacy systems to electronic QMS platforms, preferably Veeva Vault (Quality QMS).
- Demonstrated ability to write and revise Standard Operating Procedures (SOPs) in alignment with EU GMP (especially Chapter 4) and GDP requirements.
- Familiarity with risk-based decision making, including the application of ICH Q9 principles during record closure and quality actions.
- Experience collaborating across cross-functional teams, with ability to influence and guide without direct authority
#LI-CO1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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