Senior QA Specialist (inglés nivel alto imprescindible)

We are seeking a Senior QA Specialist to join ALK-Abelló at a pivotal time in our operations. This role will focus on overseeing quality assurance functions at our Contract Manufacturing Operations (CMO), ensuring compliance with company expectations and regulatory requirements. You will play a key role in driving continuous improvement in quality assurance practices and ensuring high standards are implemented across all processes.

Key Responsibilities:

1. Perform Quality Assurance activities associated with maintaining internal Quality Systems, including Change Control, Deviations, CAPA, and more.
2. Review GMP technical and validation reports for:
3. Manufacturing and packaging processes.
4. Cleaning Validation / Equipment cleaning procedures.
5. Laboratory and manufacturing equipment qualification.
6. Facilities and utilities with product contact.
7. Analytical methods validation.
8. Provide quality support for technology transfer projects.
9. Offer on-site guidance in preparing procedures and working instructions.
10. Resolve GMP issues by identifying problem areas, refining systems, and training/coaching relevant personnel.
11. Maintain permanent inspection readiness status.
12. Provide QA support for regulatory filings.
13. Prepare documentation for Material Review Board presentations and meetings.
14. Support QA Management as required.
15. Offer GMP quality expertise, advice, and assistance across the organization as needed.

Required Qualifications and Skills:

1. Minimum of 5 years' experience in the pharmaceutical/biotech industry, with a thorough knowledge of quality systems, GMP, and regulatory requirements.
2. University degree in Chemistry, Pharmacy, Biology, or equivalent.
3. Essential skills: Fluent in both written and spoken English and Spanish.
4. Thorough knowledge of oral solid forms and technology transfer projects.
5. Knowledge of sterile products regulation is a plus.
6. Expertise in interdisciplinary areas such as pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
7. Strong interpersonal and leadership skills, capable of handling organizational complexity and ambiguity, particularly in stressful situations.

What We Offer:

1. A key role within an international organization with the opportunity to make impactful contributions to quality assurance practices.
2. Competitive salary and benefits package.
3. Professional growth within a dynamic, collaborative team.

Interested?

If you’re passionate about ensuring high-quality standards and driving continuous improvement in the pharmaceutical industry, apply today to join our team at ALK-Abelló!