Head of Cqv

Proclinical are recruiting for a Head of CQV to join a biotech organisation. This role is on a permanent basis and is located in Europe.

**Responsibilities**:

- Guide CQV projects, which involves planning, scheduling, and implementing, to guarantee that projects meet timelines and goals.
- You will drive constant improvement initiatives in CQV procedures, strategies and systems to grow efficiency.
- Recognise and acknowledge concerns that raise throughout CQV actions, offering technical knowledge and assistance to resolve challenges.
- Supervise and arrange the implementation of validation protocols, which involves IQ OQ, PQ.
- Perform risk examinations and impact analysis linked to equipment, procedures, and facility changes and develop mitigation methods.
- Responsible for developing and executing methods for the CQV procedures in line with organisation best practices and regulatory needs.
- Work alongside cross-functional teams, which involves Engineering, Manufacturing, QA, and RA to assure seamless integration of CQV actions with any other divisions.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Demonstrable experience in CQV in the pharmaceutical, biotechnology or medical device organisation.
- Comprehension of cGMP, FDA, EMA, and any other regulatory necessities linked to Commissioning, Qualification, and Validation.
- Project management abilities with acquaintance in guiding CQV projects from inception to completion.
- Leadership capabilities with the ability to resolve issues,
- Communication skills both verbally and in writing.
- Expertise on risk-based approaches and strategies for CQV procedures.
- Works well with others within a cross-functional team setting.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

TechOps

Scientific