QA Associate - Niel, België - eTheRNA

eTheRNA

Geverifieerd bedrijf

Niel, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

etherna provides research and manufacturing excellence by teaming up with highly skilled scientists, researchers and technical experts who are recognized for their contributions to the industry.

We acquired substantial intellectual property and know-how over the years that support our exceptional leadership in mRNA and LNP innovation.

With a careful balance in our skillset, state-of-the-art facilities and specialized equipment we tackle complex challenges and assure efficiency in our operations.*****
General job description:

The Quality Assurance Associate supports the continuous improvement and maintenance of the Quality Management System (QMS) within the company, under the supervision of the QA Manager, and helps to ensure that all operations comply with international cGMP regulations (e.g. Eudralex Volume 4) in general and Belgian laws and regulations in particular, as well as the company's internal standards, and assures the correct detection, reporting and closure of quality events, changes and other types of quality system related events.

This position reports to the QA Manager and will be based in Niel.

Responsibilities and Duties:

The Quality Assurance Associate duties shall include, but not be limited to:

Review and approval of the blanco batch records and batch related labels
Perform label printing of critical labels, e.g. final product labels
Perform batch record review & followup release of batches
Prepare Batch Release certificates
Maintaining the (electronic) Quality Management System
QA Review & Follow up of events (including alarm handling), planned deviations, supplier complaints, OOS, CAPA, change requests
Assist in product return and product recall
Participation in

Quality Risk Management:
assess and evaluate the correctness and completeness risk assessments

Documentation management: Revision, approval, update, storage, distribution and archiving of procedures (SOPs), quality records and files
Establish product quality documentation system by writing and updating quality procedures
Execution and participation on QA oversight activities, e.g. Gemba walks
Assist in the followup of KPIs
Prepare management review documentation
Execution and participation on Internal audits
Record meeting minutes for staff meetings and audits
Training management:Keep training files up to date and inform about training status
Prepare and give QA trainings

QA Review of:
Environmental monitoring activities

Stability protocols & reports
Validation protocols & reports
Operator/process qualification
Visual inspection qualification

Release of incoming materials

Assure that good distribution practices (GDP) are applied on incoming and outgoing goods
Release of autoclaved materials
Prepare annual product quality reviews (PQRs)
Assist in supplier qualification and requalification including audits
Assist in customer qualification and requalification
Assist in the planning and execution of the Validation Master plan
Assist in QA related projects
Assist in development related projects which contribute to the scientific research and development part of the organization
Other duties as assigned
Job requirements:

Education:

Bachelor degree or Master degree, by preference in biomedicine, life sciences, pharmaceutical sciences, chemistry or equivalent experience

Experience:

Preferably of 13 years of relevant professional experience in Quality Assurance, preferably in pharmaceutical industry

Other Qualifications, Skills and Abilities:

Analytical mind, with focus on quality and eye for detail
Good data management skills: detailoriented and accurate in following instructions, record keeping and completion of reports
Scientific integrity
Advanced written and verbal communication skills
Well organized, wellstructured, handson, result focused
Able to prioritize work, to manage multiple tasks and to work under stringent timelines
Ability to foster teamwork and a collaborative atmosphere
Excellent interpersonal skills
Good knowledge of English and Dutch
Good understanding and use of MS Office (Excel, Word, PowerPoint, Outlook)
Job offer:
An exciting job in a dynamic and entrepreneurial environment with room for personal development.
Work within an innovative environment where you can learn a lot
Employment contract of unlimited duration with a competitive salary package.
Working in a fun team where collaboration, growth but above all fun are central