Job detail for QA Specialist

Job Information

Job title: QA Specialist

• Location: Beijing, China
• % Remote working and % of travel expected: N/A
• Job type: Full time
• Site/Unit: Beijing Site/ M&S China

About the job

Our Team:

The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.

• Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.

• Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.

• Provide strong quality support to innovation and business initiatives, including digital transformation projects.

• Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements.

Main :

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements

• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations

• Conducting regular audits of production processes to identify and address potential quality issues

• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor

• Managing and resolving quality-related issues in a timely and effective manner

• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed

• Leading root cause analysis investigations for quality incidents and implementing preventive measures

• Participating in internal and external audits and regulatory inspections providing support and documentation

• Reviewing batch records and associated documentation

• Developing and implementing risk management strategies to mitigate potential quality issues

• Fostering a culture of quality and continuous improvement across the organization

• Participate in deviation, complaint, and change control processes, demonstrating high independent judgment in timely identification, investigation, and resolution of deviations and complaints that may impact product quality; participate in initiating corrective and preventive actions, support CAPA implementation and verify CAPA effectiveness. Reviewing batch records and associated documentation.

• Review batch records and associated documents to ensure accuracy and compliance; draft and revise quality-related procedures and standard operating procedures(SOPs).

• CMO management: Conduct on-site inspections of the CMO

• Complete product quality review to ensure that PQR is completed in a timely manner in accordance with the corresponding procedures and GMP requirements.

Key Roles (D,A,I)

• Request corrections when GMP rules are not respected (D)

• Prioritize quality and compliance objectives (A)

• Proactively implement remediation action from findings from internal and external audits related to quality issues (D)

• Request quality improvement initiatives and strategies (D)

• Identify discrepancies and corrective/preventive actions that need to be taken (D)

• Escalate to upper management any failure in GMP execution on shopfloor (I)

• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I)

• Advise on how to present a topic and answer specific questions (A)

• Advise on risk management strategies and plans (A)

• Advise on initiatives to promote a quality-focused culture (A)

• Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D)

• Check whether all practices are done according to quality requirement; if not, assure that a deviation is opened and reported in the batch record (D)

• Review documentation for batch disposition (A)

**Additional **

HSE:

• Responsible for following the company’s HSE policy and integrated all requires into daily work. Incorporate HSE work into the work plan

• Participate the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan

About you:

Expected Experience:

• Minimum of 3 years experience in quality assurance within the pharmaceutical industry

• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

Expected Technical skills:

• Ability to analyze complex data and identify trends, issues, and solutions

• High level of accuracy and attention to detail in all quality assurance activities

• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

• Proficiency in identifying problems and implementing effective corrective actions

• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Language:

Chinese and English

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Take The Lead Behaviours: Aim Higher, Act for Patients, Be Bold and Lead Together

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!