Overview: Our client is seeking a dedicated and knowledgeable Quality Operations to support ARD to join our team. The Specialist will play a critical role by reviewing and approving various reports and protocols and in ensuring quality operations on the shop floor, supporting the implementation of new tools and requirements, and enhancing audit readiness and compliance.

Job Description

Quality Support for ARD:

• Stability and Shelf Life Reports: Review and approve stability and shelf life reports to ensure compliance with regulatory requirements.
• Validation Protocols and Reports: Review and approve validation protocols and reports, including Test Protocols (TPs).
• PAMER/Appendices: Review and approve (platformization) PAMER (Product Assessment and Manufacturing Evaluation Reports) and appendices.
• Transfer Protocols: Review and approve transfer protocols and TTP (Technology Transfer Protocols).

Quality Operations:

1. Gemba and Coaching:

• Perform regular Gemba walks on the shop floor to observe and improve processes.
• Provide coaching and support to shop floor personnel to enhance quality practices.

2. Implementation Support:

• Assist in the implementation of new tools (e.g., CDW, Veeva) and ensure adherence to new requirements.
• Provide training and support to staff on new tools and processes.

3. Audit Readiness:

• Support audit readiness activities, including audit preparation, facilitation, and CAPA (Corrective and Preventive Action) response.
• Ensure timely and effective resolution of audit findings.

4. Document Review and Approval:

• Review and approve Standard Operating Procedures (SOPs), Work Instructions (WKIs), and AMP documents.
• Review and approve equipment-related documents such as user guides.
• Challenge and approve CAPA plans to ensure they are effective and sustainable.

Profile

• Bachelor's degree in a related field (e.g., Quality Assurance, Pharmaceutical Sciences, Scientifics master) with and expertise on Analytical Testing (QC, ARD)
• Minimum of 5 years of experience in quality operations and/or ARD support within the pharmaceutical industry.
• Strong knowledge of quality management systems, regulatory requirements, and industry standards (e.g., GMP, ISO).
• Previous experience in reviewing and approving validation protocols and reports. Familiarity with stability and shelf life studies.
• Experience with audit preparation, facilitation, and CAPA management.
• Proficiency in using quality management tools (e.g., CDW, Veeva).
• Excellent attention to detail and strong analytical skills.
• Effective communication and interpersonal skills for collaboration with cross-functional teams.
• Ability to work independently and manage multiple priorities.

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.