Quality Officer Amsterdam • Prothya Biosolutions

Responsibilities:

1. Batch Record Review

• Batch record review

2. Release Preparation

• Support the release preparation activities, in order to generate a complete batch dossier package

3. Deviation Management

• Review, assess, and close minor deviations. - Perform basic Root Cause Analysis (RCA). - Escalate major and critical deviations to senior QA or management.

4. CAPA Execution & Follow-Up

• Initiate and execute CAPAs. - Track and ensure timely completion of CAPA actions. - Verify CAPA effectiveness and document findings.

5. Quality Investigations & Compliance

• Support investigations for minor product complaints and minor process deviations and events. - Ensure proper documentation and compliance with GMP regulations.

6. Change Control Support

• Support minor Change Controls related to deviations and CAPAs. - Ensure proper documentation of Change Control impact.

7. Audit & Inspection Support

• Provide input for audits and inspections regarding deviations and CAPAs. - Support preparation of CAPA-related audit responses.
• QA shopfloor activities

8. Process Improvement

• Suggest improvements in CAPA and deviation handling processes. - Review and approval of procedures and work instructions - Contribute to continuous improvement initiatives.

GxP

Officer

Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.

Your Profile:

• HBO/ Academic (master’s degree) in Life Sciences/ Pharmacy
• HBO > 2yrs experience or young Academic (MSc)
• Basic knowledge of the GMP-guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred.
• Experience with Trackwise/Mastercontrol/ SAP or similar.
• Dutch and English speaking (work proficiency) English writing skills.
• You naturally take a proactive approach are an analytical thinker and clear communicator

What we offer:

• A market-rate salary
• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A fulltime employment of 40 hours per week
• Flexible working hours after deliberation
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Good accessibility by public transport and we provide private parking;
• Sound pension provision.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.