Validation Manager

Location
Cheshire
Salary
Dependent on experience
Posted
11 Mar 2021
Closes
10 Apr 2021
Ref
J5634482
Contact
Debra Fong
Contract Type
Permanent
Hours
Full Time
Are you an experienced Validation Manager looking for a new exciting job opportunity?

We are currently looking for a Validation Manager to join a leading pharmaceutical company based in the Cheshire area.

As the Validation Manager you will be responsible for leading, authoring and performing Installation, Operational and Performance Qualifications in compliance to GMP specifically Annex 11 & 15.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Validation Manager will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for leading validation projects and complete all associated project documentation in line with regulatory expectations. You will manage, plan and execute adherence to the Site Validation Master Plan which includes Process Validation, Equipment Validation, Cleaning Validation, Computer System Validation and validation of Utilities.

2. You will also be managing and developing members of the validation team to ensure appropriate levels of training, competence and capability.

3. As the Validation Manager, it will also be your responsibility to provide relevant support for regulatory audits, submissions and other auditor request as well as ensure projects are managed in conjunction with all regulatory requirements such as cGMP.

4. Additionally, you will contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Validation Manager we are looking to identify the following on your profile and past history:

1. Relevant Scientific or Engineering degree. Experience in managing a validation department within a regulated cGMP environment and experience working in the pharmaceutical, FMCG or other regulated production operation is essential.

2. Proven experience managing and documenting an entire validation process is also required for this role. Strong understanding of pharmaceutical industry regulatory requirements with knowledge of FDA guidance, ICH guidelines, EUGMP and GAMP.

3. Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches

Key Words: Validation Manager | Process Validation | Utilities | Facilities | QA | GMP | Pharmaceutical | CSV | ICH | MHRA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.


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