(Sr.) Specialist, QS & Compliance, Biologics
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Principle Roles & Responsibilities / Accountabilities主要职责/责任
Quality and Technical Guidance
Works with the management team to support the development and oversight of robust quality systems including both implementation and operation at site level.
Supports the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators as appropriate.
Review systems and analyze data (paper or electronic) to identify specific compliance and data consistency issues.
Implements and executes the Inspection Readiness program; including Roche Corporate Inspections and Health Authority Inspections which includes site inspection preparation program management response and commitment process.
Facilitates training on all GMP & Quality Compliance programs.
Support the continuous improvement and oversight of Quality System Compliance programs and identifies and implements new technologies to improve the compliance and efficiency of QS operations.
Collaborate with project F&E MSAT manufacturing and QC teams to address quality issues.
Other related duties as assigned.
Education/Qualifications
The candidate should have at least a Degree in pharmaceutical sciences life sciences biology biotechnology chemistry chemical engineering or a related discipline.
Certification and training such as auditor training will be advantageous.
Job Required Competencies
A minimum experience of 2 years in pharmaceutical or biotechnology in quality assuranceincluding Data Integrity (ALCOA) compliance self-inspections ideally in a multinational company.
Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
Ability to apply a phase appropriate risk-based approach to QA operational decisions.
Aseptic Filling experience is required and experience in the new DP facility project is expected.
FDA/EU cGMP know-how and understanding of ICH guidelines with exposure to the international regulatory network is preferred
Able to logically solve problems in order to find timely solutions.
Ability to work well independently and within a team.
Strong follow-up and organizational skills.
Fluent oral and written communication skills in English with technical writing experience required.
Project management skills are preferred.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Senior IC
Key Skills
- Variation Orders
- QS
- Construction Projects
- Cost Estimates
- Sub-Contractors
- Civil Engineering
- Cost Control
- Construction Documents
- Autocad
- Cost Planning
- Contract Documents
- Contractual Claims
- Cost Analysis
- Feasibility Studies
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
