Job Description

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

Position: QA Validation Engineer

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We are currently expanding our team and are looking for a QA Validation Engineer on site with a client. In summary, you will be supporting the Quality team with independent, effective and timely rewiew and approval services and able to ensure that tasks are performed according to requirements.

Key Responsibilities:

Draft, compile, review and update appropriate policies and procedures in support of the validation activities on site Assess, review and approve changes that may have an impact on the validation status of the facility, processes or systems on site Review and approve / authorize validation protocol documents and reports Act as a Validation Co-ordinator in projects that are deemed to have product quality impact, chair the Validation Working Party meetings, and lead the conduct of validation activities to ensure that validation / regulatory requirements are met Perform the QA role in projects to ensure that the manufacture complies with GMP requirements documentation Lead the cleaning validation programme to ensure that all cleaning methods used are validated in compliance with regulatory requirements Ensure that validation review of systems or processes are conducted on a periodic basis to ensure that the validation status is maintained, and make recommendations for re-validation as required, pending outcome of the validation review

Requirements:

Minimum bachelor's degree in the relevant science/ engineering discipline At least 5 years of relevant experience in the pharmaceutical industry Extensive knowledge of GMP and validation Extensive knowledge of quality and manufacturing processes Good knowledge of corporate management systems Detailed knowledge of regulatory processes Good knowledge of GMP and validation Good knowledge of quality and manufacturing process knowledge

What's In It for You?

Exposure to the major Pharmaceutical Companies in the industry. Annual leave benefits. Full Health coverage and benefits. Training and Development allowance.

What's Next?

If you are interested in applying for this position, please send an email to allison.aquino@cmcexpertisedelivered.com.

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation, or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.