At a Glance
- Tasks: Ensure compliance with pharmaceutical guidelines and support quality excellence on-site.
- Company: Join a leading pharmaceutical company committed to quality and innovation.
- Benefits: Gain valuable experience in a dynamic environment with potential for career growth.
- Other info: Maternity cover position with shift work required.
- Why this job: Make a real impact in the pharmaceutical industry while developing your skills.
- Qualifications: Relevant science degree and 2-3 years of radiopharmacy experience preferred.
The predicted salary is between 30000 - 40000 € per year.
Ensure site compliance with the Specials guidelines, the current international pharmaceutical legislation and related guidelines, along with company requirements. Support a culture of excellence for the site. Shift work required. NOTE: The vacancy is a maternity cover (fixed-term contract).
Essential Functions
- GMP/ Production Compliance
- Review compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC.
- Documentation management: review and update existing SOPs and forms, and write new SOPs.
- Assist with deviations, incidents and investigations, OOS, CAPA, change control and release of incoming materials.
- Review QC tests and Micro results, manage out‑of‑specification results.
- Ensure timely completion and update of all quality records and trackers.
- Support the site to remain GMP‑compliant by ensuring SOPs are up to date.
- Write QC validation/verification protocols.
- Execute QC analytical method validation and verification protocols.
- Maintain equipment calibration, requalification and validation logs.
- Schedule calibration, requalification and validation activities.
- Maintain supplier qualification systems and support supplier qualification performance.
- Complaints/CAPA/Change Controls/Deviations
- Assist with QMS elements such as deviations, complaints, OOS, CAPA, change control, recall, micro out of specification, risk assessments and related trending.
- Quality and Compliance
- Record logs for incoming material, fridge, freezers, isolator checks and other logs.
- Raise and complete deviation reports OOS and MOOS where applicable.
- Participate in root cause analysis, CAPA/change control identification and effectiveness checks.
- Communicate effectively with colleagues to facilitate efficiency in production and quality matters.
- Ensure all GMP guidelines and processes are followed.
- Inspect incoming materials as part of quality inspections.
- Participate in Gemba walk and self‑inspection.
- Complete assigned training within the specified time frame.
- Ensure QC equipment calibration checks are up to date.
- Provide QMS data for preparation of quality management reports.
- Corporate Guidelines
- Adhere to legal and organisational procedures & guidelines concerning quality, safety, health and environmental issues.
- Train technicians in SPECT QC, PET QC and GFR processing once qualified.
- QC Activities
- Perform quality control testing on all manufactured products (SPECT & PET) at the LRP according to SmPC, EP guidelines and internal procedures.
- Review completed incoming material forms.
- Manage environmental monitoring process and record data on the trends spreadsheet.
- Read microbial plates, broth and sterility samples.
- Interpret and record microbiological data; report out‑of‑specifications and take appropriate action in a timely manner.
- Review and maintain QC logbooks and data to ensure site meets objectives in relation to data integrity.
- Support validation activities, preparation and execution of protocols.
- Liaise with quality management on validation strategy and training.
- Keep VMP up to date.
- Maintain tidiness of the QC lab.
- Set Up Production Orders
- Set up orders for the purchase of QC materials.
- Check stock levels of QC materials.
Requirements
- Knowledge of radiation (desirable)
- Shift work required.
Education/Experience
- Relevant science degree.
- 2–3 years of radiopharmacy experience.
- Radiopharmacy or laboratory experience desirable.
- Analytical and Excel skills desirable.
- Validation and protocol execution experience desirable.
- Experience working within the quality department desirable.
Knowledge
- Working knowledge of pharmaceutical chemistry and GMP required.
- Knowledge of equipment qualification and process validation desirable.
Skills
- Excellent team player.
- Basic computer skills.
- Good customer relationship skills.
- Communication skills.
- Practical ability.
- Excellent time‑keeping competencies.
- Stress handling.
- Excellent attention to detail.
Equal Opportunity Employer Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
QA/QC Officer employer: Curium Pharma
Curium is an exceptional employer that fosters a culture of excellence and compliance within the pharmaceutical industry. Located in a dynamic environment, we offer our QA/QC Officers not only competitive benefits but also opportunities for professional growth and development through hands-on experience in quality management systems. Join us to be part of a team that values respect, dignity, and equality, ensuring that every employee can thrive in their role while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land QA/QC Officer
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QA/QC roles. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on GMP guidelines and QC processes. We recommend practising common interview questions related to quality control and compliance. Show them you know your stuff and are ready to hit the ground running!
✨Tip Number 3
Don’t forget to showcase your attention to detail! Bring examples of how you've maintained compliance or improved processes in past roles. This will help you stand out as a candidate who truly understands the importance of quality in pharmaceuticals.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Curium.
We think you need these skills to ace QA/QC Officer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the QA/QC Officer role. Highlight your relevant experience in GMP compliance, documentation management, and quality control testing. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how your background makes you a great fit for our team. Keep it concise but impactful – we love a good story!
Show Off Your Attention to Detail:In QA/QC, attention to detail is key. When filling out your application, double-check for any typos or errors. We appreciate candidates who take the time to ensure everything is spot on – it reflects your commitment to quality!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the info you need about the role and our company culture there!
How to prepare for a job interview at Curium Pharma
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and the specific guidelines related to pharmaceuticals. Be ready to discuss how you've applied these in your previous roles, especially in relation to compliance and documentation management.
✨Showcase Your Analytical Skills
Prepare to talk about your experience with QC testing and analytical methods. Bring examples of how you've handled out-of-specification results or participated in root cause analysis. This will demonstrate your practical ability and attention to detail.
✨Familiarise Yourself with SOPs
Since you'll be reviewing and updating SOPs, it’s crucial to understand their importance in maintaining quality standards. Think of instances where you've contributed to SOP development or compliance, and be ready to share those experiences.
✨Communicate Effectively
Effective communication is key in a QA/QC role. Prepare to discuss how you've collaborated with colleagues to improve production efficiency and quality matters. Highlight any training or mentoring you've done, as this shows your team player attitude.
