About the Company:
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our clients cultural fabric and woven into how they do business every day. Their commitment to respect the dignity and diversity of all is embedded in their Credo.
About the Role:
You would be responsible to make sure that systems within the quality system are adequately (CSV & TMV) validated.
You will report directly to the Manager of Microbiology & Lab
Responsibilities:
– Act as a Subject Matter Expert (SME) during projects, regulatory and notified body audits/inspections.
– Support in improving test method validations like writing protocols and reports.
– Responsible for writing and developing IQ/OQ/PQ/ CSV protocols and reports for new and existing laboratory equipment.
– Acts as a project leader for laboratory validation projects.
– Supports day-to day laboratory trouble shooting for test equipment and unexpected test results.
Requirements:
– University/Bachelor’s Degree or equivalent thinking.
– 6-8 years of work experience, preferably in the pharmaceutical or medical-device industry.
– Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971.
– Experience with quality assurance systems (QMS).
– Working knowledge of MS Office, Excel.
Interested? If you see your self or you know someone who can be a fit for this role then do not hesitate to APPLY for this role and know more details about it.
Similar jobs
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.