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QC Validation Engineer

2 months ago

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

Position: QC Validation Engineer

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.

Job Description:

We are currently expanding our team and are looking for a QC Validation Engineer to work on projects on site with a client. In summary, you will be supporting Quality Control Laboratories with independent, effective and timely testing services and able to ensure that tasks are performed according to requirements with review/verification of results and problem solving for issues identified.


Key Responsibilities:

  • Assist in the qualification / validation of new equipment / replacement of equipment project for Ocrevus 2.0 Technology transfer.
  • Collaborate with multi functions to arrange, plan and ensure smooth running of the execution activities.
  • Draft qualification / validation protocols / reports, execute qualification / validation of equipment in accordance with relevant policies, standards, procedures and guidelines timely
  • Ensuring the implementation of safety policies during all site activities including pre-planning, review of safe work plans, preparation of site work documentation and monitoring of safe work methods during execution;
  • Draft and manage qualification / validation exceptions, deviation and/or investigations encountered during acceptance test execution representing as Qualification / Validation SME.
  • Setup master data in Laboratory Execution System relating according to test methods relating to Ocrevus SC 2.0.
  • Execute qualification of master data in Laboratory Execution System in accordance with relevant policies, standards, procedures and guidelines timely.
  • Support other technical changes and duties as required.

Requirements:

  • Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). ·
  • Min 5 years of relevant working experience in GMP environments is preferred.
  • Excellent communication skills, both written and verbal, in English.
  • Ability to multitask and work in a fast paced environment with competing priorities.
  • Great team player. Strong interpersonal and communication skills and ability to develop close working relationships and work collaboratively with internal and external contacts at all levels

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.


Tell employers what skills you have

Biochemistry
Ability to Multitask
Excellent Communication Skills
Management Consulting
Cell
Quality Control
Technology Transfer
GMP
Root Cause Analysis
Biotechnology
Biology
Team Player
Life Sciences
Terminology
Test Execution
Laboratory
Analytical Method Validation