QA Validation Engineer

2 weeks ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

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**

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.

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