Job Description
Bring energy, knowledge, innovatiofn to carry out the following:
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
- Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
- Conduct work activities in a safe and compliant manner.
- Support weekend or on-call duty on select time frames to support manufacturing as POC (point of contact) and POE (point of escalation).
- Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to cover compliance topics.
- Coordinates compliance-specific tasks within Drug Substance Process Operations and represents them in cross-group meetings such as Change Review-, Risk Assessment- Deviation-boards, GMBR boards and Audits preparations
- Lead n investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
- Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
- Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
What skills you will need:
- Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 6 years + experience in Biotech industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
- Competent in analyzing complex situations and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
- Demonstrated experience in QRM, Investigations and Problem solving
- Familiarity with contamination control and batch release requirement
- Experience in quality management systems such as Veeva, SAP, PAS-X etc..
- Experience in Quality Assurance, Quality Control within the Biological and/or pharmaceutical industry.
Preferred Experience and Skills:
- Commissioning and Qualification experience
- Problem, Deviation, and Change Management experience
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
- Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.
- Familiarity with contamination control and batch release requirements
So, if you are ready to:
Invent solutions to meet unmet healthcare needs,please apply today
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
Job Posting End Date:07/05/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.