Quality Assurance Coordinator supporting Supply Chain Logistics in contact lens production. Ensuring quality standards compliance and managing quality documentation in the European Distribution Center.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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