Senior Quality Officer

Prothya Biosolutions; Amsterdam; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Holiday allowance

Year-end bonus

Private parking or good transport link

Job summary

Prothya Biosolutions seeks a QA professional to lead QP batch release preparation, batch record reviews and QMS governance. You will supervise QA Officers, interact with OMCL, and ensure timely regulatory documentation and CAPA follow-up.

Key responsibilities include deviations handling, CAPA investigations, and maintenance of GMP procedures. Strong GMP knowledge, Dutch/English proficiency, and proactive, analytical communication are essential for success.

Qualifications

• Bachelor or Master’s degree in Life Sciences or Pharmacy.
• HBO >2 yrs experience or MSc.
• Basic knowledge of GMP guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred.
• Experience with TrackWise, MasterControl, SAP or similar.
• Dutch and English working proficiency; English writing skills.
• Proactive, analytical thinker with clear communication.

Responsibilities

• Batch release preparation and supervision of QA officers in communication with OMCL.
• Review batch records and ensure readiness for QP batch release (intermediates, Drug Substances, Drug Products and Finished Products).
• Support QA operations and CAPA management; track effectiveness and assist audits.
• Provide validation support, review equipment validations.
• Lead deviations, CAPA investigations, and regulatory documentation.
• Ensure GxP compliance and proper documentation across QA activities.

Skills

Analytical thinking

Clear communication

Proactive attitude

Education

Bachelor/Master in Life Sciences/Pharmacy

Tools

TrackWise

MasterControl

SAP

Job description

Preparation of QP batch release for Products (Quality records, Batch recordreview, release documentation), overall QMS compliance relating to QA Operational tasks. You play a key role in executing structured simple Root Cause Analyses (RCA), tracking CAPA effectiveness, and supporting audit readiness. Your work contributes to maintaining product quality, reducing recurring issues, and ensuring continuous process improvements within the organization.

Responsibilities

Batch Release

• Batch record review
• Preparation for QP batch release (intermediates, Drug Substances, DrugProducts and Finished Products)
• Supervise QA Officers (or junior personnel in general ) in Communication with OMCL
• Physical release in the product Warehouse

QMS

• Assessment and review, follow-up and timely closure of minor/major/(Critical if SME) deviations
• Assist extended Root Cause Analyse (RCA) with known techniques.
• Assessment and review, follow-up and timely closure of OOS / OOL /OOT records.
• Assist Quality engineers in Investigation and timely closure of Product Quality Complaints
• Handling of returned goods
• Review, follow-up and timely closure of Corrective and Preventive actions (CAPA’s)
• Execute deliveries from change controls

Validation support

• Review & Approval of routine Equipment validations

Inspections

• SME (Subject Matter Expert) during Self inspection as auditee, and customer audit. Back office in regulatory audit. Support presentation of process in regulatory audits
• Training On the Job of QA Ops staff in Deviations, CAPA’s the related systems

Compliance review

• Writing of GMP-procedures
• review and approval of GMP-documents (e.g. GMP-procedures, master batch records)

Documentation and reporting

• Deliver quality raw data for monthly Metrics and Quality Management Review and for Product Quality Review.

QA on the shopfloor

People management/ leadership (example)

• Coach junior member team. Possible project leader if SME.

Stakeholder Management (example)

• Support Quality lead in stakeholder management

GxP

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:

• Bachelor/ 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 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
• 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;