QA Validation Engineer

COALESCE MANAGEMENT CONSULTING PTE. LIMITED; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A leading company in management consulting, specializing in Life Sciences and Technology, is looking for a QA Validation Engineer. The role involves supporting the Quality team with independent review and approval services, ensuring compliance with regulatory and validation requirements. You'll work closely with various teams to maintain validation status and support key quality initiatives in collaboration with major pharmaceutical clients.

Benefits

Exposure to major Pharmaceutical Companies

Annual leave benefits

Full Health coverage and benefits

Training and Development allowance

Qualifications

• At least 5 years of relevant experience in the pharmaceutical industry.
• Extensive knowledge of GMP and validation.
• Detailed knowledge of regulatory processes.

Responsibilities

• Draft, compile, review, and update policies for validation activities.
• Review and approve validation protocol documents.
• Act as Validation Coordinator to ensure compliance with GMP.

Skills

Knowledge of GMP

Validation expertise

Quality and manufacturing processes

Detail-oriented

Regulatory knowledge

Education

Bachelor's degree in relevant science/engineering discipline

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

Job Description:

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 [e-mail].

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.