Senior QA Specialist (inglés nivel alto imprescindible)

ALK-Abelló A / S; Comunidad Valenciana; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior QA Specialist to enhance quality assurance practices within its Contract Manufacturing Operations. This pivotal role involves ensuring compliance with regulatory requirements and implementing high standards across processes. The ideal candidate will bring over five years of experience in the pharmaceutical or biotech industry, with a strong background in quality systems and GMP. Join a dynamic, collaborative team where your expertise will drive continuous improvement and impactful contributions to quality assurance. If you are passionate about maintaining high-quality standards, this opportunity is perfect for you.

Servicios

Competitive salary

Benefits package

Professional growth opportunities

Collaborative team environment

Formación

• 5+ years in pharmaceutical/biotech with knowledge of quality systems and GMP.
• University degree in Chemistry, Pharmacy, Biology or equivalent required.

Responsabilidades

• Oversee quality assurance functions ensuring compliance with regulations.
• Perform QA activities related to internal Quality Systems and GMP.

Conocimientos

Quality Assurance

GMP Compliance

Regulatory Requirements

Interpersonal Skills

Leadership Skills

Analytical Chemistry

Microbiology

Data Integrity

Fluent in English

Fluent in Spanish

Educación

University degree in Chemistry

University degree in Pharmacy

University degree in Biology

Descripción del empleo

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!