Qc Management System Lead
hace 2 meses
**About us**
Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners created in response to the unmet need for manufacturing of gene therapies. Our goal is to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.
We are excited for our next QC Management System Lead to join the Viralgen team
**About the role**
We are seeking a QC Management System Lead who will play a key role on the structure of the company in Quality Control, reporting to the QC Head.
The QC Management System Lead will be directly involved in the activities related to the Quality Management System within QC laboratory:
The lead will also collaborate with other departments in the development and transfer of the processes in a commercial plant. Will work with the Regulatory Affairs in order to develop the documentation required by the Regulatory Agencies. Will participate in meetings with the client in order to set a strategy for implementing processes and analysis.
**Responsibilities**
- cGMP practices in documentation and execution of job functions.
- Participate in laboratory investigations including Deviations and OOS/OOT/OOE.
- Quality Management System indicators; Deviations, OOS/OOT/OOE, CAPA and Change Control, within the QC laboratory tracking.
- Generate and review SOPs and FORMs,
- Verification, Transfer and Validation of analytical methods protocols and reports revision.
- Stability Studies protocols and reports revision.
- Product Specification revision.
- Water for Injection plant annual reports revision.
- Environmental monitoring annual report revision.
- Participate in daily and monthly meetings.
- Fostering a dynamic, communicative, and respectful work culture within the team and between different departments.
**About you**
- Bachelor’s Degree in Pharmacy, Chemistry, Biology, Microbiology, Biotechnology or equivalent.
- 5 years related experience in a pharmaceutical company in a GMP regulated environment.
- Knowledge of GMPs, ICH and Pharmacopoeias.
- Must be flexible with working hours
- Ability to communicate in English and Spanish.
- Self-motivated and used to work in a multidisciplinary environment.
- Demonstrated ability to work both independently and in a team environment.
- Demonstrated ability to work well under pressure and meet tight deadlines.
- Demonstrated passion for producing high-quality work.
- Good interpersonal skills, including communication and self-management.
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