Marketplace Technical

Validation Manager

Runcorn, England, Cheshire
22 Jun 2021
02 Jul 2021
Andrew Williams
Full Time
Contract Type
Experience Level

Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Validation Manager to

manage, plan and execute adherence to the Validation Master Plan which includes Process Validation, Equipment Validation, Cleaning Validation, Computer System Validation and validation of Utilities. Responsible for leading, authoring and performing Installation, Operational and Performance Qualifications in compliance to GMP specifically Annex 11 & 15.

Duties may include:

* Lead validation projects and complete all associated project documentation in line with regulatory expectations

* Management and development of members of the Validation Team to ensure appropriate levels of training, competence and capability

* Manage, coordinate and guide the execution of the site validation master plan

* Effectively monitor and communicate the validation projects execution plan to other departments

* Manage project activities against required delivery timelines and report progress to stakeholders

* Provide the relevant support for regulatory audits, submissions and other auditor requests.

* Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments

* Author, review and execute validation protocols (this requires gaining an in-depth knowledge of the product/system to be able to determine what the necessary output is and if it is meeting predefined criteria)

* Maintain validation documentation through the validation lifecycle

* Participate in periodic reviews during product life cycle to deepen process performance understanding and drive process improvement

* Provide oversight and validation expertise during the development of new product and new technologies

* Contribute to the overall validation strategy for the site as well as act as a technical point of contact for internal and external stakeholders

* Actively maintain and update knowledge and expertise of current developments, standards and operating practices within the pharmaceutical industry

* Ensure projects are managed in conjunction with all regulatory requirements such as health & safety and cGMP

* Ensure compliance with environment, health and safety rules, signage and instructions

* Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

Skills and experience:

* Suitable scientific or engineering degree

* Experience managing a validation department within a regulated environment

* Experience working in a pharmaceutical, FMCG or other regulated production operation

* Strong understanding of pharmaceutical industry regulatory requirements with knowledge of FDA guidance, ICH guidelines, EUGMP and GAMP

* Strong documentation bias. Experience managing and documenting an entire validation process. Documentation produced must comply with both internal SOPs and externals regulations.

* Ability to work consistently and compliantly, following standard operating procedures and quality policies

* Good written communication skills and a structured approach to working

* Good communication skills; able to work with various team members across all functions

* Good technical knowledge of pharmaceutical manufacturing techniques and procedures

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