Quality Assurance Packaging Consultant

Conteúdo do emprego

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it’s the best of both worlds….

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a QA packaging Consultantto join one of our clients, a leading pharmaceutical company located in Louvain-La-Neuve, Belgium. Work from home and the site, permanent employment with benefits.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:

• Ensuring the Quality oversight of packaging and labelling operations of Clinical Trials (CT) performed by Collaboration Partners (CPs) and Alliance Partners located in the EU and Asia are in compliance with both regulatory and the company Corporate GMP/GDP requirements/standards for CTs supplies
• Ensure compliance with EU and Belgian regulatory requirements, GMP/GDP and the company standards of activities performed
• Working with the PD and PR&D functions as well as key members of the Global Quality Development Unit, Business Partners, CPs and Regulatory Affairs
• Contributing to the realization of the Quality Objectives in connection with the GMP’s activities of PR&D
• Supporting activities performed by QA groups
• Acting as the key contact for the creation of the QP declaration, manage the GMP certificate, collect appropriate metrics related to this activity

Main Job Tasks and Responsibilities:

Packaging/Labelling QA Activities:

• Updating the Quality Managers/QPs/RPs of any non-conformity and/or issues that may affect quality and/or integrity of the CT Materials (finished and/or semi-finished)
• Maintaining deep knowledge/expertise with the packaging/labelling processes
• Creating a direct link between the company and Partners (business, CPs, etc…) for Quality activities
• Act as a Subject Matter Expert in link with the Quality Packaging partners from the US
• Participate in the Quality oversight of the CPs with the Qualification Representative through metrics analysis, trending, PiPs, etc. as applicable
• Reviewing/approving incomings used in packaging/labelling operations
• Reviewing/ approving instructions for packaging/labelling operations and packaging/labelling batch records for studies performed by the different collaboration and alliance partners
• Participating in deviation assessments/investigations/approval related to Packaging/Labelling activities
• Participating in change control assessments/review/approval related to Packaging/Labelling activities
• Reviewing Standards/Procedures/Tools and reference documents from the company Quality Systems related to Packaging/Labelling activities
• Reviewing DCPR/QA with CPs
• Conducting self-inspections
• Participating in regulatory inspections and ensure audit readiness

Compliance:

• Ensure regulatory and GMP/GDP requirements are met for activities performed
• Ensure documents are handled and stored in compliance with the company Quality System Requirements
• Ensure monitoring of changes in regulations affecting the company activities

Documentation:

• Actively participate in populating databases used in packaging/labelling department, this includes but not limited to: SAP, TrackWise, Metrics Database
• Actively participate in the PR&D Quality System by identifying, reviewing of procedures, tools or any other documents that require QA approval
• Management of QP declaration files, Manufacturing Authorisation, GMP Certificates

External relations/others:

• Interact with the PD team as well as Global Quality Development Units and Business Units
• Interact with the CPs involved in Packaging/Labelling activities and other contracting Manufacturers
• Interact with the Regulatory teams and Regulatory Authorities
• Collaborate to projects and actions related to packaging/labelling activities

Health, Safety and Environment:

• Carry out the activities in accordance with company and site safety and environmental requirements
• Confidentiality
• Ensure that confidential information remains confidential

Education and Experience:

• Master’s degree, preferably from scientific background

Skills:

• Demonstrated teamwork and interpersonal skills
• Strong organisation and self-management skills
• Ability to use and apply multiple computer applications
• Multitasking
• Change management
• Effective written and verbal communication skills
• High initiative, flexible and positive attitude
• Accurate and detail minded
• Fluent in English

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Job Types: Full-time, Permanent contract

Pay: €48,000.00 per year

Benefits:

• Cell phone reimbursement
• Food allowance
• Fuel card
• Hospitalization insurance
• Internet reimbursement
• Mileage reimbursement
• Work from home

Schedule:

• Day shift