Senior SpecialistAssociate Manager, CMO Quality Management
Share
Job Location:
Monthly Salary:
Posted on:
Yesterday
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
The Opprtunities:
Principle Roles & Responsibilities / Accountabilities
Quality Oversight
Define and deploy the schedule for Quality Oversight in CMO site
The scope of quality oversight should cover all the CMO production related areas and quality activities including warehouse laboratory production plants facility/utility/equipment etc. and the batch record
review etc.
Drive the correction and prevention for the observation from quality oversight
Regular analysis and report for the observation from quality oversight
Oversee CMO product batch release process
Provide QA Support to production scheduling change control and validation.
Ensure on-time batch disposition per Roche SDP (Supply Delivery Performance).
Ensure products are not sold or supplied before QP/AP release each production batch is produced and controlled in accordance with the requirements of the Marketing Authorization and other regulations relevant.
Provide QA oversight on direct materials/API management.
Ensure direct material/API release on-time
Oversee material quality including Specification Artwork SAP/MES master data Change DMS/CAPA new material qualification quality management etc.
Support local supplier quality management including audit Quality Agreement etc.
Coordination and handling for CMO quality related issue
Involve and support the CMO products related unplanned event.
Involve and support planned event.
Involve and support the investigation of CMO related OOS/OOT
Lead the investigation of CMO product related complaints
Other quality related activities
Draft and review the CMO product APQR.
Involve and support the inspection by HA and Roche Global inspection on CMO sites.
Coordinate and involve in the Self-inspection on CMO sites by SRPL.
Support the job of maintaining the business needed licenses.
Maintain the CMO quality agreements.
Qualify the CMO QA for batch record review.
Involve quality related projects
As the quality bridge between Roche and CMO sites ensure the quality information exchange timely.
Lead and promote the continual improvement of quality management system in CMO site
By deploy the QSMR QCS and QRM
By communication of the specific technical topics
Complete other tasks assigned by senior leaders
Who you are:
Education/Qualifications
Bachelor Degree (4 years education of Pharmacy Pharmaceutical bioengineering Chemistry or equivalent education level)
Graduate or higher-level Degree is preferred.
Job Required Competencies
Experience (may vary depending on site size/scope)
5 or more years work experience in the pharmaceutical or related industry
3 or more years experience in a commercially licensed GMP facility
Experience on solid and/or aseptic processing is preferred
Knowledge/Skills/Competencies
Expert knowledge of Quality System and QA principles practices and standards for the pharmaceutical industry.
Expert knowledge of cGMP relevant to the pharmaceutical industry
Strong knowledge of pharmaceutical biotechnology or medical device related product operations including local and international quality regulations.
Project management skills
Demonstrate excellent verbal and written communication skills in English
Focus on value and customer
Learn for the future
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:
Chief
Key Skills
- Portfolio Management
- Wealth Management
- Financial Services
- Hybris
- Microsoft Word
- Banking
- Cash Management
- Data Management
- Microsoft Powerpoint
- Securities Law
- Microsoft Excel
- Internet Of Things
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.
