Quality Validation Specialist

Cpl Healthcare; London; On-site; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Quality Validation Specialist to enhance their Quality Operations team. This role focuses on ensuring compliance of electronic systems within the Quality Control Laboratory with GMP standards. You'll be responsible for maintaining the Electronic TrackWise Quality Management System, supporting qualification and validation processes, and acting as a subject matter expert in CSV activities. Join a dynamic environment where your expertise will contribute significantly to the quality of life-saving products in the pharmaceutical sector. If you have a passion for quality assurance and compliance, this opportunity is perfect for you.

Qualifications

• Proficient knowledge of electronic systems, CSV, and GAMP requirements.
• Good understanding of GMP guidelines and regulations.

Responsibilities

• Ensure compliance of electronic systems with GMP and corporate expectations.
• Act as a Quality Subject Matter Expert for Qualification and Validation.

Skills

Electronic Systems Knowledge

CSV and GAMP Requirements

Data Integrity Understanding

Quality Control Systems Knowledge

Analytical Software Understanding

Technical Data Interpretation

GMP Guidelines Knowledge

Qualification and Validation Knowledge

Job description

Job Title: Quality Validation Specialist (CSV)

Job Type: Full Time, Permanent Position.

Location: Great London, Hertfordshire area, UK. (On site)

Remuneration: Competitive salary and package.

Cpl Life Sciences is partnering with a growing pharmaceutical company that specialise in Oncology and Neurology. Due to growth within the business, they are looking for a Quality Validation Specialist to join the Quality Operations team.

This role you will be responsible for ensuring that electronic systems within the Quality Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures.

Role Responsibilities:

·Ensure EML’s Electronic TrackWise Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and Corporate expectations.

·Provide input to the review and writing of any associated quality policies, systems and procedures as required.

·Support the maintenance and administration of EML’s Electronic TrackWise Quality Management System (QMS) to maintain an effective QMS to meet EML’s requirements.

·Support the effective management of the administration of QC laboratory system applications providing independence of access for administrator activities.

·Ensure Qualification and Validation of EML equipment, processes, systems is/are performed in line with EML procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required.

·Ensure the maintenance of EML procedures supporting Qualification and Validation ensuring they are current with updated requirements for Qualification and Validation and cGMP, cGxP expectations.

·To act as a Quality Subject Matter Expert in relation to ensure compliance of Qualification, Validation and all CSV activities within EML control.

Requirements/Qualifications:

·Ability to understand and analyse user requirements to facilitate changes and system improvements.

·Proficient knowledge of electronic systems, CSV and GAMP requirements.

·Good understanding of the requirements of data integrity and application to system management.

·Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.

·Ability to interpret complex data and present key findings.

·Ability to describe technical information in easy-to-understand terms.

·Good understanding of GMP Guidelines and Regulations.

·Knowledge of the qualification and validation requirements for equipment and electronic systems.

·Maintain knowledge and understanding of technical advancements in electronic systems.

For more information, please forward your up-to-date CV to [e-mail]

Please ensure you hold the full right to work in the UK.