QA Validation Engineer

7 days ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time
Roles & Responsibilities

Position: QA Validation Engineer

We are Coalesce Management Consulting - 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.

We are currently expanding our team and are looking for a QA Validation Engineer to support projects on-site with a client.

Key Responsibilities:

  • Reviewing manufacturing batch records, lot disposition, and production logbooks
  • Ensure that all pharmaceutical projects comply with relevant industry standards, including FDA regulations.
  • Reviewing and approving of vendor protocols, validation protocols, configuration specifications, requirement specification, requirement traceability matrix, summary report for Qualification
  • Reviewing and approving CIP and SIP qualification and requalification documents, cleaning verification and validation documents
  • Oversee non-conformance handling and equipment calibration
  • Conduct internal audits and review technical documentation

Requirements:

  • Degree related to Science or Engineering.
  • Good knowledge and experience in GMP facilities.
  • At least 5 years of experience in manufacturing, and biopharmaceutical industries.
  • Ability to multitask and work in a fast-paced environment with competing priorities.
  • Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels.
  • Exhibit continuous improvement mindset and innovative thinking

What's in it for you?

  • Greatest exposure to the Big Pharmaceutical Companies in the industry.
  • Annual leave benefits.
  • Full Health coverage and benefits.
  • Training and Development allowance.

If you are interested in applying for this position, please send an email to

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.

Tell employers what skills you have
Ability to Multitask
Management Consulting
FMEA
Risk Assessment
GMP
Investigation
Cleaning Validation
Protocol
Python
Communication Skills
Regulatory Requirements
Terminology
Manufacturing
Commissioning
Mapping
Utility Systems

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