Hybrid Associate QA Manager

at Ardena Careers

• Job title: Associate QA Manager
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: No Education Requirement
• Location requirements: Hybrid, Ghent, Belgium

About the role

• Quality Assurance Manager overseeing pharmaceutical quality systems and compliance. Ensuring manufacturing and documentation meet GMP standards.

Responsibilities

• The Quality Assurance Manager is responsible for day-to-day implementation of the Pharmaceutical Quality System in the organization
• Drafts and keeps up to date the procedures and process flows related to non-sterile as well as sterile manufacturing
• Provides or supports in training of the personnel for what concerns the Quality processes and GMP awareness
• Responsible for the daily follow up of the pharmaceutical management system: deviations, changes, CAPAs, complaints, supplier qualification, logbooks, equipment qualification, destructions, shipments, reference and retention samples
• QA review of equipment and maintenance related documentation
• QA oversight of Environmental Monitoring in sterile production facility
• Assists during contractor audits, contract giver audits and performs internal audits
• Assists the Qualified Person in the preparation of the batch certifications
• Reviews and approves master and executed (project-related) documents (e.g. Batch Record Documentation, Incoming Material Records)

Requirements

• You have a Master degree in Life Sciences (Pharmaceutical Sciences, Biomedical Sciences, (Bio)Chemistry)
• You have knowledge of GMP quality system and regulatory requirements
• A first experience in Quality Assurance in pharma is a plus
• You are solution driven, keeping timelines and budget in mind
• You are continuously looking for improvement
• You have strong communication skills, able to listen and analyze a quality issue and explaining the proposed solution in an accurate manner
• You can express yourself fluently in English

Benefits

• An attractive and tailor-made remuneration package including extra-legal benefits such as meal- and eco vouchers
• Group- and hospitalization insurance
• Compensation if you come to work by bike
• Option for bike lease
• Flexible working hours
• 32 days holiday a year
• A true learning environment where you will have the ability to grow your skills
• A dynamic working environment with nice colleagues
• Open straightforward but also caring culture