QA Responsible Person (RP) (12-month contract Outside IR35)
Posted 1 day ago by Adecco
Negotiable
Outside
Remote
England, United Kingdom
Summary: The QA Specialist & Responsible Person (RP) role is a 12-month remote contract position with occasional onsite attendance, focused on ensuring quality assurance and compliance within the pharmaceutical sector. The position involves maintaining the Quality Management System, ensuring adherence to relevant standards, and managing supplier controls. The ideal candidate will have proven experience in quality assurance and hold an RP qualification. Strong communication and organizational skills are essential for success in this role.
Key Responsibilities:
- Support the Quality team in maintaining the organisation's Quality Management System (QMS).
- Ensure compliance with ISO 9001, GMP, and GDP standards, as well as internal procedures.
- Raise non-conformances, deviations, and change requests, ensuring all trackers are meticulously maintained.
- Manage the supplier controls system, including evaluations and assessments.
- Analyse process performance and prepare presentations for Quality Management review meetings.
- Conduct internal audits and ensure adherence to audit schedules.
- Drive continual improvement initiatives and maintain internal KPIs.
- Communicate changes to the QMS to team members effectively.
- Ensure compliance with GDP and relevant EU/HPRA guidelines as the Responsible Person.
- Uphold the conditions of the Wholesale Distribution Authorisation, ensuring all medicinal products are handled under strict GDP conditions.
- Conduct timely bona fides evaluations of suppliers and customers.
- Oversee self-inspections and audits according to the audit schedule.
- Serve as the primary contact for the HPRA, reporting changes in facilities or products promptly.
- Prioritise patient and product safety at all times.
Key Skills:
- Proven experience in quality assurance, specifically in a pharmaceutical or healthcare setting.
- RP qualification.
- Being named on a Wholesale Distribution Authorisation (WDA).
- Strong knowledge of GDP, GMP, and ISO standards.
- Excellent organisational and communication skills.
- Ability to work independently and collaboratively in a team environment.
- A proactive approach to problem-solving and continuous improvement.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
QA Specialist & Responsible Person (RP) - 12-month contract Remote role with occasional onsite attendance at client locations. One of our clients , an award-winning pharmaceutical consulting company, is looking for a RP to join them on a contract basis. If you're passionate about quality assurance and compliance in the pharmaceutical sector, we want to hear from you!
Key Responsibilities:
- Support the Quality team in maintaining the organisation's Quality Management System (QMS).
- Ensure compliance with ISO 9001, GMP, and GDP standards, as well as internal procedures.
- Raise non-conformances, deviations, and change requests, ensuring all trackers are meticulously maintained.
- Manage the supplier controls system, including evaluations and assessments.
- Analyse process performance and prepare presentations for Quality Management review meetings.
- Conduct internal audits and ensure adherence to audit schedules.
- Drive continual improvement initiatives and maintain internal KPIs.
- Communicate changes to the QMS to team members effectively.
Specific Responsibilities for Responsible Person:
- Ensure compliance with GDP and relevant EU/HPRA guidelines.
- Uphold the conditions of the Wholesale Distribution Authorisation, ensuring all medicinal products are handled under strict GDP conditions.
- Conduct timely bona fides evaluations of suppliers and customers.
- Oversee self-inspections and audits according to the audit schedule.
- Serve as the primary contact for the HPRA, reporting changes in facilities or products promptly.
- Prioritise patient and product safety at all times.
What We're Looking For:
- Proven experience in quality assurance, specifically in a pharmaceutical or healthcare setting.
- RP qualification.
- Being named on a Wholesale Distribution Authorisation (WDA).
- Strong knowledge of GDP, GMP, and ISO standards.
- Excellent organisational and communication skills.
- Ability to work independently and collaboratively in a team environment.
- A proactive approach to problem-solving and continuous improvement.
Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.