Senior QA Specialist ingls nivel alto imprescindible

ALK-Abelló; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as a Senior QA Specialist, where you will oversee quality assurance functions in a dynamic pharmaceutical environment. This role is pivotal for ensuring compliance with regulatory standards and driving continuous improvement in quality practices. You will leverage your extensive experience in the pharmaceutical industry to maintain high-quality standards and support technology transfer projects. With a competitive salary and opportunities for professional growth, this is your chance to make a significant impact in an international organization committed to excellence.

Servicios

Competitive salary and benefits package

Professional growth opportunities

Dynamic, collaborative team environment

Formación

• 5+ years in pharmaceutical/biotech with knowledge of quality systems and GMP.
• Expertise in interdisciplinary areas like analytical chemistry and microbiology.

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

Analytical Chemistry

Interpersonal Skills

Leadership Skills

Problem Solving

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 ALKAbell 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 onsite guidance in preparing procedures and work 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 ALKAbell!

Additional Details :

• Experience Level: Senior IC
• Key Skills: Invoicing, Information Technology Sales, IT Support, Audio Visual, Database Administration
• Employment Type: Full-Time
• Vacancy: 1