Quality Assurance Specialist (Pharma)
One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals that would contribute to its success by joining the new team.
We are looking for a Quality Assurance Specialists that would be responsible for ensuring that our generic pharmaceutical products are manufactured accurately, uniformly, and in full compliance with EU GMP and GDP standards. You would also ensure product quality and compliance throughout the release process and the entire product life cycle management.
Office location: Warsaw
Hybrid model: 3 days office-based, 2 days home-office
Main responsibilities:
- Handling of complaints
- Perform Product Quality Review
- Handling of deviations
- Handling supplier and customer inquiries
- Handling of change controls
- Handling of stability data from suppliers
- Evaluation of Elemental Impurities and Nitrosamine risk assessment
- Review of batch journals
- Approval of Master Batch Record
Requirements:
- Educational Background: Master of pharmaceutical science, master of medicinal chemistry, master of science in chemistry, chemical engineer, master in biochemistry, Master of manufacturing engineering.
- Experience: Minimum of 5 years of experience in Quality Assurance, Quality Control or production from a pharmaceutical production site or other highly regulated industries.
- Communication: Excellent English verbal and written communication skills. Ability to effectively describe complex quality related information to internal stakeholders.
- Problem-Solving: Strong analytical and problem-solving skills. Ability to make informed decisions and manage risks.
- Knowledge: Knowledge of global regulatory requirements and guidelines related to quality incl. EU GMP and EU GDP.
- Team-player Skills: Demonstrated ability to be part of a cross-functional team with shared goals.
Work values:
- Ability to thrive in a fast-paced environment
- Adaptability to changing priorities based on market needs
- Independence and responsibility for own areas and tasks
- Awareness of the importance of timely deliver
- Sufficient level of compliance, detail and accuracy oriented when needed.
- Collaborate with CMO’s to ensure the right compliance level and further escalation if needed.
- Continuous improvement mindset
What you'll get in return
- Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
- Work in a hybrid model (3 days in the office per week)
- Potential for a permanent contract after an initial 3-month period.
- Comprehensive medical coverage through Medicover.
- Sports Card: Access to various sports facilities and activities.
- Life insurance coverage for added security.
- Opportunity to be involved in the transition of processes.
- Attractive and competitive salary.
Hays Poland sp. z o.o. jest agencją zatrudnienia zarejestrowaną w rejestrze prowadzonym przez Marszałka Województwa Mazowieckiego pod numerem 361.