Validation Expert

Vor 6 Tagen

Basel, Schweiz Skillhubs Vollzeit

Our client is a leading player in the biopharmaceutical industry, known for our innovative approach and groundbreaking products. Their commitment to excellence has positioned them at the forefront of healthcare innovation, and they continue to push the boundaries of what's possible in medicine.

As a **Validation Expert**, you will play a crucial role in ensuring the integrity of our cleaning validation processes across sterile production, solids packaging, and sterile antibiotics production. You will be instrumental in managing and improving validation procedures, supporting tech transfers, and representing the validation concept during regulatory inspections and audits.

**Key Responsibilities**
- Develop and manage the cleaning validation concept for various production areas.
- Serve as the focal point for the Cleaning Validation area, coordinating tasks and providing support.
- Drive improvements in the cleaning validation process and take initiative in concept enhancement.
- Manage launches and tech transfers related to cleaning validations.
- Represent the cleaning validation concept during inspections and audits by regulatory authorities.
- Collaborate with internal and external stakeholders, including laboratories and production teams, to implement and document cleaning validation activities.
- Conduct troubleshooting, root cause analysis, and quality impact assessments for cleaning-related production issues.
- Ensure compliance with Product Quality Standards (PQS) and regulatory requirements.

**Qualifications**
- Several years of practical experience in cleaning validation, pharmaceutical development, production, Manufacturing Science and Technology (MSAT), or quality departments.
- Demonstrated flexibility, agility, and commitment to fostering a lean culture.
- Strong team player with a **lean agile** and creative mindset.
- In-depth knowledge of Good Manufacturing Practices (GMP) and a keen interest in analytics.

**Benefits**
- A dynamic and challenging environment in a leading biopharmaceutical company.
- Opportunities for professional development and growth.
- A collaborative team culture that supports innovation and improvement.

**Job Types**: 100%, Permanent

Schedule:

- 8 Hour Shift

Ability to Commute:

- Basel, BS (preferred)

Ability to Relocate:

- Basel, BS: Relocate before starting work (preferred)

Work Location: In person

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