Quality Control Analyst Chemist

We are currently seeking a dynamic and results oriented Quality Control Analyst to perform chemistry and biochemistry analyses of in-process samples, bulk drug substance (BDS), and non-routine samples. This is an opportunity to join a fast-growing consulting group that values entrepreneurial spirit and offers an exciting journey of growth. - Singapore

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About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.

About us

Open Position

Mission

Tasks and responsibilities

Perform all tasks associated with QC lab operations.
Administration of LIMS Portfolio.
Coordination for QC C3ME system.
QC system administrator.
Continuous improvement.
Support Investigation.
Project Management: Analytical Equipment Qualification.
Regulatory Filing and Method launches.
Invalid results tracking, trending, and investigation.
Unexpected results investigation.
Control Trend establishment and investigation.
Reference Standard and Reagent qualifications.
Compendia review.
Audit Preparation and Involvement and other tasks as assigned.
Ensure timely and compliant execution of assigned tests in accordance with Standard Operating Procedures.
Conduct equipment calibration and maintenance.
Review and approve QC records/logbooks.
Participate in Out of Specification (OOS), Invalid test, and Lab Deviation Investigation Write-Up.
Write/revise SOPs, forms, training qualifications (TQ), and risk assessments (RA).
Provide technical support to QC Personnel for laboratory troubleshooting.
Participate in method validation/transfer or equipment qualification as needed.
Ensure proper handling and disposal of waste for a safe working environment.
Conduct 5S and maintain good housekeeping of the Analytical Lab area.
Support Operation Excellence initiatives and projects for safety performance and continuous improvement.
Assist in internal and external compliance audits.
Adhere to site’s EHS requirements.
Commit to a fair and respectful relationship with other employees following Takeda’s Code of Conduct.
Perform any other duties assigned by Supervisor.

Studies

Your profile

Degree in Chemistry, Biochemistry, Biotechnology, or Diploma in Chemistry, Biochemistry, Biotechnology.
A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical, or related manufacturing environment.
Demonstrated ability to collaborate with cross-functional or cross-sites to achieve objectives.
Demonstrated experience in the area of method validation, method transfer, method verification, Unexpected Results investigation.
Demonstrated strong project management capability and the ability to lead multiple projects.
Demonstrated ability to collaborate with cross-functional or cross-sites to achieve objectives.
Six Sigma Greenbelt training would be an advantage.

Technical skills and competenecs:

Basic assay verification/validation know-how.
Team player and independent contributor.
DMAIC tools experience.
Presentation skills for audits and validation teams.
Experience in problem-solving (facilitation and application of tools).
Basic statistical knowledge and experience with data analysis.
Knowledge concerning cGMP, especially lab-related topics such as method validation life cycle, unexpected results, critical reagent qualification.
Basic knowledge about regulatory requirements concerning analytical test methods and licenses.
Substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
Knowledge in Microsoft Office.
Keen eye for detailed process steps and identification of gaps/opportunities.
Must be detail-oriented.
Project Management Skills.
Good verbal and written communication and good organizational skills.
Strategically and business-oriented thinking.