Quality Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
8 hours 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
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
Thats what makes us Roche.
Principle Roles & Responsibilities / Accountabilities
(Major functions of the position)
Compliance
- Support the implementation of regulation at Roche Shanghai.
- Prepare and Organize Basic/ ILT /OJT related to regulatory compliance training.
and Audit Management
- Support HA inspections internal and external audits and paper-based inspections (HAs inspections Corporates/GCA audits).
- Lead the activity to define collect and check pre-requests and inspection requests as per timeline with close collaboration with SMEs.
- Support the external inspections ensure all the readiness activities are completed and inspection compliance risks are escalated and communicated within appropriate management levels in time.
and CMO Self-inspection
- Support the establishment and execution of the E2E self-inspection program to ensure the program drives continuous improvement of the site and CMOs systems processes and quality compliance performance.
- Maintain and consciously improve internal auditor pool qualification and capability.
annual report
- Support MAH annual report related activities for Roche Shanghai.
- Organize and coordinate other departments to collect data information for MAH annual report and submit MAH annual report in NMPA annual report system after final review and approval.
- Continuously improve annual report process.
document and record management.
- Support for the GMP document and record management at site.
- Oversee the site GMP document and record retention and destruction.
- Support credit rating assessment for Roche Shanghai
- Supporting other businesses from Quality System and Compliance team if needs (e.g. Change Control PQS DI etc.)
- Other activities assigned by line manager.
Qualification and Experience
Education/Qualifications
- Bachelors Degree required (Pharmacy Science Biology Biochemistry or bio engineering is preferred); Graduate or higher-level Degree is preferred.
- 2 or more years Quality Unit experience in the pharmaceutical industry.
Job Required Competencies
- Good knowledge of Quality System and Compliance principles practices and standards for the pharmaceutical industry.
- Good knowledge of cGMP relevant to the pharmaceutical industry knowledge of the local and international GMP regulations.
- Good understanding with audit or inspection management.
- Manage oneself/demonstrate leadership within own role.
- Well communication skill and good accountability of problem solving.
- Good at English listening speaking reading and writing.
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:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
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.
