Quality Associate Manager

Job description

The Position

Primary Purpose of Job (Job Summary)

• Responsible for the establishment, approval and implementation of drug and medical devices SOPs, Ensure drug and medical devices business in compliance with the compliance requirements of China GSP and PQS.

• Support for setting up quality system，make sure the quality system continuous improvement and effective operation.

• Support business operation to Ensure commercial product fast to patient.

Principle Roles & Responsibilities / Accountabilities
Quality System and Compliance

• Guide all the departments and staff to implement the Drug Administration Law and Good Supply Practice (GSP) Regulation of drug and medical devices.

• Responsible for drafting, revising, guiding and supervising the SOPs of quality department.

• Guide for drafting, revising and approval the SOPs of other departments.

• According to the quality policy and objective, ensure the achievement of department objectives.

• Responsible for PQS implementation and updating according to RSPT PQS plan.

• Responsible for local HA GSP inspection of drug and medical devices and CAPA follow up.

• Support for Roche PTQF audit and CAPA follow up.

• Responsible for the internal annual inspection and CAPA follow up. Support to complete quality internal risk assessment report.

• Responsible for 3rd party logistics annual quality audits and CAPA follow up.

• Support for setting up RSPT quality system.  Fully communicate with SRPL quality system BPM as   coordinator.

• Responsible for assessment and handling UPE as quality owner in operation.

• Responsible for assessment and handling PE as quality controller in operation.

• Responsible for all kind of quality risk assessments as QRM quality in operation.

• Responsible for RSPT training management as local training expert.  Fully communicate with SRPL system BPM as coordinator.

GSP Routine Operation Management

• Support for reviewing paper documents for the data integrity, effectiveness of first-sale enterprise, first-sale variety and first-sale customer which are submitted from procurement department and sales department.

•  Responsible for establish archives of vender/customer and the product quality files.

• Responsible for supervise 3rd party logistics related quality work. Such as goods receive inspection, storage maintenance, distribution and transportation etc. 

• Fully communicate with 3rd party logistics and be responsible for checking, confirm and dealing with the unqualified products.

• Responsible for timely reporting to Shanghai monitoring platform for purchasing, selling information.

• Responsible for the collection and feedback on quality information.

• Support for the investigation of quality accidents processing and report.

• Responsible or reporting counterfeit pharmaceuticals.

• Responsible for recall or mock recall management.

Release Management

• Responsible for setting up and maintenance quality mater data.

• Responsible for coordination temperature assessment, follow up with customers and 3rd party logistics for every shipment. If necessary, issue discrepancy process for transportation temperature excursion and coordinator with global expert for evaluation.

• Support for custom clearance and follow up the sample to SIFDC/NIFDC for every batch.

• Responsible for supplementary test and ATT test management.

• Responsible for checking the release documents for every batch and finial release of qualified products.

Quality support for T1 distributors 

• Responsible for quality oversight and audit T1 distribution as leader.

• Responsible for quality evaluation for new T1 distributor request and CAPA follow up(if appropriate)
• Responsible for prepare T1 Distributor cold chain quality audit plan and conduct audit according to annual audit plan, continue to follow up CAPA in order to be completed in time.
• Support for quality training and guidance to distributor and pharmacy.
• Guide quality related work in the business activities.

Qualification and Experience

Education/Qualifications

Academic requirement:

• Bachelor degree or above
• Pharmacy, Chemistry, Biochemistry and equivalent disciplines
• More than 5 years of pharmaceutical quality management
• Licensed pharmacist（priority）

Job Required Competencies

• Good accountability of GSP understanding and implementing.

• The ability to correctly judge and ensure the implementation of quality management.

• Knowledge and experience in company operation and quality management.

• Well communication skill and good accountability of problem solving.

• Language skill: Good at English, listening, speaking, reading and writing.

• Office skill：Win-word, Excel, PowerPoint

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 is an Equal Opportunity Employer.