Qc Specialist

1 week ago

Singapore Amaris Consulting Full time

**Who are we?**:
**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you

**Interviews** (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities

**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you
**Job description**:
**About the job**:

- Lead projects for method validation/verification/transfer to introduce new or remediated QC methods for testing existing and new products.
- Prepare and maintain method validation/verification/transfer Protocols, Reports, ensuring compliance with GMP and other standards.
- Ensure timely release of methods and equipment to support commercial production, manufacturing investigations, and product investigations.
- Lead projects for Analytical Equipment Qualification, including authoring qualification documents and providing technical advice for laboratory-related troubleshooting.
- Coordinate QC method document changes for regulatory submission and author regulatory submission documents.
- Perform trending for laboratory invalid assays and lead investigations for invalid results and trend violations.
- Lead method-related investigations for unexpected results and prepare control assignment Protocol/Report for controls as required.
- Coordinate the assessment of new/revised compendial documents on local methods and raw materials.
- Identify and drive improvements for assays, support problem-solving and improvement projects, and drive harmonization of methods.
- Support audit preparation and present investigation/issues at audits.
- Coach and mentor junior QC Specialists, and cover for another QC specialist in their absence.
- Adhere to EHS requirements, Takeda’s Code of Conduct, and perform other duties as assigned.

**About you**:
**Education and Experience**:

- Degree in Chemistry, Biochemistry, Biotechnology or equivalent.
- At least 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
- Six Sigma Greenbelt training and experience in method validation, method transfer, method verification, and Unexpected Results investigation.
- Proven ability to collaborate with cross-functional or cross-site teams.

**Key Skills and Competencies**:

- Basic assay verification/validation know-how and DMAIC tools experience.
- Proficient in problem-solving and data analysis with basic statistical knowledge.
- Knowledge of cGMP, regulatory requirements concerning analytical test methods and licenses.
- Proficient in Microsoft Office with good project management, communication, and organizational skills.
- Demonstrated strategic and business-oriented thinking with good verbal and written communication skills.

**Equal opportunity

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