Spclst, Quality Systems & Compliance
MSD España · Salamanca, Castilla and Leon, Spain
- On site
- Full-time
- $85,000 / year
- Salamanca, Castilla and Leon, Spain
Job highlights
- Execute product validation activities like aseptic simulation and cleaning.
- Manage quality events, CAPAs, and change controls.
- Create and review quality documentation.
- Participate in internal and external audits.
- Leverage advanced knowledge of quality systems and regulations.
About the role
Quality Systems & Compliance Specialist
An exciting opportunity has opened up for a Quality Systems & Compliance Specialist. In this role, you will be responsible for reviewing and ensuring that necessary Validations (aseptic simulations, process validation, and cleaning validation) are performed for manufactured products.
What You Will Do
Contribute with energy, knowledge, innovation, and leadership to:
As a Validation Technician:
- Execution of Validation activities (aseptic simulation, process/product, and cleaning validation).
As a Quality Systems Technician:
- Management of Events, CAPAs, and Change Controls (as a member of the Quality team).
- Creation/review/approval of documentation.
- Management of Quality information.
- Participation in internal, regulatory, and corporate audits.
What Skills You Will Need
To succeed in this role, you likely have:
- Bachelor's Degree in Health Sciences (preferably Pharmacy, Master's in Pharmaceutical Industry).
- Relevant professional experience in the pharmaceutical sector.
- Knowledge of the cleaning validation process.
- Proficiency in Spanish/Castilian.
- Advanced knowledge of English.
- Knowledge of validations.
- Regulatory knowledge in Good Manufacturing Practices (GMP) and applicable Pharmacopoeias.
- Knowledge in Document Systems.
- Advanced knowledge of Quality System tools (change controls, deviation management, out-of-specification results, CAPA management, validations, etc.).
- Knowledge of manufacturing processes for biological and sterile products is a plus.
- Experience in project participation, transfers, and audits is a plus.
- Experience in risk management, statistical tools, and continuous improvement methodologies is a plus.
Why Join Us?
As a company, we are committed to "Inventing for Life" in everything we do. We put the patient at the center and work to find solutions and treatments for some of the world's most complex health needs.
We pride ourselves on being a company that values diversity, talent, and commitment. Real innovation happens when different ideas meet in an inclusive environment.
If you are ready… apply today.
Key skills/competency
- Quality Systems
- Compliance
- Validation
- CAPA Management
- Change Control
- Auditing
- GMP
- Pharmaceutical Industry
- Documentation Management
- Regulatory Affairs
Skills & topics
- Quality Systems
- Compliance
- Validation Specialist
- Pharmaceutical Quality
- GMP
- Regulatory Affairs
- CAPA
- Change Control
- Auditing
- MSD España
How to get hired
- Tailor your resume: Highlight your pharmaceutical industry experience, validation knowledge (cleaning, process, aseptic), and familiarity with GMP and pharmacopoeias.
- Showcase quality systems expertise: Emphasize your experience with CAPA, change control, deviation management, and documentation.
- Demonstrate regulatory acumen: Detail your understanding of Corrective and Preventive Actions, and any audit participation.
- Highlight language skills: Clearly state your advanced Spanish and English proficiency as required.
- Prepare for technical and behavioral interviews: Be ready to discuss your validation execution and quality management experience.
Technical preparation
Review GMP and pharmacopoeia guidelines.,Practice writing validation protocols and reports.,Study CAPA and change control documentation.,Understand aseptic, process, and cleaning validation.
Behavioral questions
Describe a time you managed a quality event.,How do you ensure documentation accuracy?,How do you handle competing quality priorities?,Share your experience in regulatory audits.
Frequently asked questions
- What are the key validation activities for a Quality Systems & Compliance Specialist at MSD España?
- The Quality Systems & Compliance Specialist at MSD España is primarily responsible for executing and managing various validation activities, including aseptic simulations, process validation, and cleaning validation for manufactured products. This ensures that all products meet stringent quality and regulatory standards.
- What specific quality system tools are important for this role at MSD España?
- For this role at MSD España, advanced knowledge of Quality System tools is crucial. This includes proficiency in managing change controls, handling deviations, addressing out-of-specification results, managing CAPAs, and conducting validations. Familiarity with document management systems is also essential.
- What level of English proficiency is required for the Quality Systems & Compliance Specialist position at MSD España?
- The Quality Systems & Compliance Specialist role at MSD España requires advanced knowledge of English. This is in addition to the required proficiency in Spanish/Castilian, reflecting the global nature of the pharmaceutical industry and MSD's operations.
- What educational background is preferred for the Quality Systems & Compliance Specialist at MSD España?
- MSD España prefers candidates for the Quality Systems & Compliance Specialist role to have a Bachelor's Degree in Health Sciences, with a strong preference for Pharmacy. A Master's degree in the Pharmaceutical Industry is also highly valued, indicating a specialized understanding of the field.
- Does MSD España offer opportunities for professional development in quality and compliance roles?
- Yes, MSD España emphasizes continuous learning and professional development. The company culture values talent and commitment, encouraging employees to innovate and grow within their roles, particularly in specialized areas like quality systems and compliance.
- What is MSD España's commitment to patient care and innovation?
- MSD España is deeply committed to 'Inventing for Life,' placing the patient at the center of all their efforts. They strive to develop solutions and treatments for complex global health needs, driving innovation through a diverse and inclusive environment.
- How important is experience with GMP and pharmacopoeias for this role?
- Knowledge of regulatory requirements, specifically Good Manufacturing Practices (GMP) and applicable Pharmacopoeias, is essential for the Quality Systems & Compliance Specialist position at MSD España. This ensures adherence to industry standards and regulatory guidelines.
- Are there specific manufacturing processes that are considered a plus for this role?
- Yes, while not strictly required, knowledge of manufacturing processes for biological and sterile products is considered a valuable asset for the Quality Systems & Compliance Specialist role at MSD España. This indicates a broader understanding of pharmaceutical production.