Qc Validation Engineer

7 days ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

**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.

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.

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