Quality Operations Senior Specialist
Gdańsk, PL
Boost your career with us
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
If you're passionate about maintaining the highest GMP standards and want to contribute to the development of biosimilar medicines, we have a role for you.
Your responsibilities include, but are not limited to:
- Ensuring proper preparation, assessment, and approval of GMP and quality documentation.
- Participating in pharmaceutical inspections and audits conducted by national and international regulatory authorities.
- Developing, implementing, and maintaining the Quality Management System in accordance with internal and external regulations.
- Reviewing batch records and certifying manufacturing steps for drug substances, bulk products, and investigational medicinal products (IMPs).
- Making independent decisions regarding product release or rejection in the capacity of an Authorized Person.
- Supporting change control, risk assessment, and deviation management processes.
- Conducting and/or participating in internal and external audits.
- Verifying production processes for compliance with GMP through regular shop floor presence.
- Delivering GMP training and supporting continuous improvement initiatives.
If you have:
- Minimum 5 years of experience in the pharmaceutical industry, including at least 2 years in product evaluation within QA or QC.
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Higher education in biology, chemistry, pharmacy, biotechnology, or related field.
- Strong knowledge of GMP requirements and pharmaceutical law, especially in the ICH environment.
- Proven working knowledge of the QMS.
- Proficiency in English, both spoken and written.
- Strong decision-making and teamwork skills.
- Familiarity with quality systems and manufacturing technologies for pharmaceuticals.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Additional free day.
- and more..
Why you should work with us
Contact us
career@polpharmabiologics.com