Quality Assurance Specialist III, External Manufacturing — Vaxcyte
NewCHF 49'500 - 75'000
Vaxcyte · Visp (VS)
- Location
- Visp
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 49'500 - 75'000
Role overview
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
- Join our Mission to Protect Humankind!
- Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
- Technology Transfer and Validation: May participate as a QA representative on Technology Transfer and/or Validation Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both internal and external transfers.
- Documentation and Reporting: Reviewing, editing, or approving controlled documents.
Main responsibilities
- Technology Transfer and Validation: May participate as a QA representative on Technology Transfer and/or Validation Teams where responsibilities include providing guidance on QA procedures and policies as well as review of documents for both internal and external transfers.
- Documentation and Reporting: Reviewing, editing, or approving controlled documents.
- Maintain accurate and thorough documentation of related quality activities.
- Regulatory Compliance: Ensure all disposition-related activities comply with global regulatory requirements, including FDA, EMA, ICH guidelines, and other applicable regulations.
- Cross-functional Collaboration: Work closely with global manufacturing, and external vendors to address quality issues and support product development and commercialization.
- Continuous Improvement: Drive improvements in batch record review processes and procedures by identifying gaps, recommending solutions, and implementing best practices.
- Participate in activities for the implementation of the ERP platform.
- Support internal audits as required. Requirements:
- Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
- Minimum of 5 years of experience in quality assurance, batch record review, manufacturing, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
Company and context
- Great organization skills and have an attention to detail.
- In-depth understanding of biologics manufacturing operations.
- Good ability to prioritize multiple assignments and changing priorities.
- Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses.
- Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams.
- Reports to: Senior Manager, Quality Assurance Location: Visp, Switzerland Work Arrangement: Hybrid (minimum of 3 days per week) Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
- We are an equal opportunity employer.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Additional details
- Our work together is guided by four enduring core values: RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
- The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices) and regulatory guidelines within the pharmaceutical industry. Essential Functions:
- Support internal audits as required.
Notes and original content
- The ideal candidate will possess in-depth knowledge of cGMP (current Good Manufacturing Practices) and regulatory guidelines within the pharmaceutical industry.
- Essential Functions:
- Requirements:
