quality gmp project support specialist - 10348.

Job summary:

Primary Purpose / Regulatory Responsibilities:

This position provides support to a group of Global Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development (intermediate to Finished Product), including submissions, launches, product improvements and phase out. 

This is achieved through close partnering with the GQL and other functions in Quality Organization at the company and in collaboration with Global Regulatory Affairs, Safety, the company’s Supply and Technology Solutions and other internal teams.

Major responsibilities:

Key responsibilities will include a support role with respect to: 

• Product Change Control Committee preparation and change controls follow-up

• Maintenance and lifecycle management of QA product flows 

• Audits and Inspection anticipation and readiness

• Product metrics

• Review of Annual Stability Plan

• SOPs and other control documents writing, review and approval as needed

• Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s)) 

• Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)

• Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed

• Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed

Additionally, the Global Quality Lead Support will represent the Global Quality Lead team when assigned to projects and initiatives.

For commercial products it can also include a support role for: 

• Product Quality Complaint Committee preparation and complaints oversight

• Product recall and product escalation meeting preparation 

• Annual report (i.e., reporting of change controls to Health authorities…)

• Yearly Biological Product Report

Education & qualification:

• Bachelor’s Degree.

Competencies:

• Minimum of 3 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing, or Quality Control would be an asset.

• Fluent and confident use of English language verbally and in reading & writing.

• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.

• Must be able to work autonomously for the assigned activities with limited supervision.

• Must be skilled and experienced in operating across cultures and in a multi-cultural environment.

• Must be able to independently analyze data and information to draw conclusions and make effective decisions. 

• Must have the ability and agility to adapt to different type of products, tasks and Quality Leads in a collaborative mindset.

• Must be able to identify and suggest harmonization and synergies opportunities to improve ways of working across global products.

• Must be able to deliver presentations or reports adapted to the audience.

• Must possess good interpersonal, verbal, and written communication skills.

• Must have the ability to identify risks and propose corrective actions within areas of expertise.

• Experience in GMP audits and inspections would be an advantage.

• Project management skills would be an asset.

• Experience in Data Integrity assessment would be an asset.

• Understanding of CMC Regulatory requirements would be an asset.

Consultancy

We offer an attractive salary with extra-legal advantages: 

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car 

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as freelance is also possible.