Interim QA Consultant
Posted 1 week ago by QCS Staffing
Negotiable
Undetermined
Undetermined
Surrey, England, United Kingdom
Summary: The Interim QA Consultant role involves supporting the Quality System Manager in the structured closure of legacy Quality Management System (QMS) records for a specialty pharmaceutical company in Surrey, England. The position requires a risk-based approach to record management and migration to Veeva Vault Quality QMS modules. The consultant will also assist in preparing training materials and ensure compliance with procedural documentation. This is a 4-month contract position focused on quality assurance within a regulated pharmaceutical environment.
Key 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.
- Work collaboratively in cross-functional teams.
Key Skills:
- 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.
Salary (Rate): undetermined
City: Surrey
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Interim QA Consultant - England, Surrey - 4 Month Contract
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
Requirements:
- 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
If this role is of interest, please apply now!