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The Position

Principle Roles & Responsibilities / Accountabilities:

GMP Training Management

Act as GMP training process as well as learning business process owner, develop GMP training system and procedures to ensure the training effectiveness of employees who perform GMP activities to meet Roche quality system and health authority (China/EMA/FDA) requirements.Maintain and optimize the GMP training system to improve employees' understanding of GMP, regulations and other requirements.Develop and implement annual GMP Training Plan in site.Review and Approve of training material, training plan, and job description.Support in learning system maintenance and contact with Global Learning Services (GLS) to maintain training data timely and accurately.Site contact person with global learning network.

GMP Document and Record management

As GMP document and record management process as well as business pricess owner, maintain and improve GMP document and record management process at site, and ensure its compliance with applicable laws and regulations.Oversee the site GMP document and record retention and destruction.GMP documents and records compliance review and approval.Site contact person with global GMP document management network.Site contact person with external file service provider.

Site Master File

Act as the Site Master File business process owner, maintain and manage site master file.Update site master file with related departments periodically as required.Ensure that the site master file and its related processes are consistent with regulations and Roche global PQS requirements.

Regulatory Compliance

Support the implementation of regulation related to SRPL GMP/MAH.Take part in external communication with HAs as needed; maintain Drug Manufacturing License of SRPL with close collaboration with SMEs, as applicable.File the company facility/key organization change to local HA as per regulation in a timely manner to ensure the compliance of activities.Prepare and Organize Basic/ ILT /OJT related to regulatory compliance training.

Inspection and Audit Management

Support of HA inspections, internal and external audits and paper-based inspections (HAs inspections, Corporates/Enabling Compliance team audits).Notify all relevant inspection information before, during and after the inspections to all relevant parties in a timely manner and ensure inspection readiness.Support the response process and follow up on the mitigation activities, including coordination and interface with Global Functions and/or network sites as required.

MAH 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 final review and approvalContinuously improve annual report process

Management Review of Quality and Quality Metrics

Support Management Review of Quality and provide quality metrics reporting and data analysis as site required.

Others

Support and coordinate the implementation of new issued regulations.Support the monitoring of the new issued regulations implementation.Organize credit rating assessment for Roche ShanghaiCoordinating to handle HA Consultation, Survey, and Sampling activities.Other activities assigned by line manager.

Qualification and Experience

Education/Qualifications

Bachelor Degree or above (or with an intermediate professional technique certificate or a pharmacist’s license).Pharmacy, Chemistry, Biochemistry and equivalent preferred.At least 3-5 years’ experience in Quality Unit or Production of scaled or joint venture Pharma Company.

Leadership Competencies

Models IntegrityFocus on value and customerAlign for successDeliver resultsLearn for the future

Job Required Competencies

Good accountability of GMP understanding and implementing.Good knowledge of Quality System principles, practices and standards for the pharmaceutical industry.Knowledge and experience in production and quality management.Manage oneself/demonstrate lead ship within own role.Well communication skill and good accountability of problem solving.Good at English, listening, speaking, reading and writing.Good at office software: Word, Excel, Power Point.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche China consists of the full value chain of Pharmaceuticals and Diagnostics fields, from early research, clinical development, manufacturing to commercialization. With more than 7,000 employees, Roche China is now working to develop itself into Roche's third global strategic center after Basel and San Francisco, and making sustained efforts to fulfill its long-term commitment to China, so as to meet Chinese patients’ unmet needs.

Roche is an Equal Opportunity Employer.