Quality Assurance Specialist

Responsibilities:

1. Overall responsibility for the management of the SLS
2. Acting as the main contact for any issue related to the Seeds
3. Setting and writing company policy and related procedures in support of SLS management
4. Leading gap analysis for prioritization products and executing risk mitigation plans
5. Supporting SLS routine day-to-day activities, coordinating interdisciplinary team meetings, and managing documentation
6. Supervising seed storage and release for manufacturing
7. Collaborating with R&D to establish working procedures for Archive SLS
8. Supporting SLS for product development and manufacturing
9. Handling deviations, performing risk management, and creating CAPA plans
10. Improving existing processes and implementing new ones
11. Handling/supporting change controls
12. Serving as a key quality assurance point person for plant/R&D projects
13. Working directly with managers to ensure quality standards are met

Qualifications

1. :Preferred: M.Sc. degree in Life Sciences, Biotechnology, or Veterinary Medicine
2. .Minimum 2-4 years of relevant experience in the biotechnology or pharmaceutical industry (mandatory)
3. .Strong biological understanding and experience required
4. .Project management experience is a plus
5. .High-level English proficiency (mandatory)
6. .Expert-level knowledge of GMP regulations, guidance documents, and industry best practices
7. .Strong working knowledge of industry compendia, regulations, and standards, including USP/Ph. Eur., GMP, EMA, and ICH
8. .Experience in quality assurance methodologies like change controls, CAPA, deviations, and risk management