Job purpose
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.
Responsibilities
- Perform chemistry, biochemistry analysis of lab samples, Raw materials and non-routine samples.
- Ensure tests assigned are performed in a timely manner in compliance to Standard Operating procedures.
- Perform equipment calibration and maintenance.
- Perform review/approval of QC records/ logbooks.
- Perform trending of lab results.
- Initiate and participate in Out of Specification (OOS), Invalid test and Lab Deviation Investigation Write-Up and assist in timely closure of laboratory invalid results, lab investigation and CAPA.
- Write/revise SOPs, forms, training qualifications (TQ) and risk assessments (RA).
- Provide technical support to QC Personnel in laboratory related troubleshooting e.g. lab equipment failure, method
- Ensure proper, safe handling and disposal of waste; ensuring a safe working environment.
- Carry out 6S and ensures good housekeeping of Analytical Lab area.
- Support and participates in Operation Excellence initiatives (such as GEMBA and GMP walk).
- Participate in projects towards improving safety performance and continuous improvement initiatives.
- Assist Supervisor to support internal and external compliance audits.
- Adherence to site's EHS requirements.
- Commit to a fair and respectful relationship with other employees and behaviours in accordance to the Code of Conduct.
- Perform any other duties assigned by Supervisor.
Qualifications and Experience
- Bachelor's degree in chemistry, Biochemistry, Biotechnology or equivalent, preferably with more 2-4 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment
- Knowledge in Lab equipments
- Knowledge in Empower and LIMS
- Knowledge in Microsoft Office
Benefits
- Willingness to continuously improve, grow with new challenges and travel
- Self-organizing, flat hierarchy
- Become part of an established company with a start-up mindset
- Possibility to shape the Arcondis culture and build the team/community
- Flexible workplace
