质量运营高级专员-淄博

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

General

Responsible for planning and managing Quality oversight & operational activities for contract manufacturing operations (CMOs) to meet compliance and business requirements and anticipate future needs.

This position will also work directly with internal and external stakeholders to provide sustaining quality and compliance leadership and routine support related to current commercialized products.

Ensures that performance and quality of products conform to established standards and regulatory guidelines to ensure patient safety.

Key Accountabilities

• Manage all quality records & documents related to CMO according to company Governance, respective quality system, Quality Agreement and ensure the compliance (i.e. but not limited to Deviation, Change Control, Investigation, etc).
• Drive timely periodic quality review and risk assessment of CMO management and ensures the compliance and appropriate corrective & preventive actions are identified and implemented.
• As Delegation Qualified Person to be responsible for Batch Disposition. Review the batch documentation according to the predefined requirements, performs Batch Certification and authorizes the Batch COA/COC, ensure that the production and testing of each batch of released products are in accordance with the relevant marketing authorization, the registration requirements and specifications.
• Ensure that all pharmaceutical products manufactured by External Manufacturer are certified according to GMP requirements and specifications.
• Responsible for development, availability, and compliance of Product Quality Reviews.
• Participates in and provides support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives.
• Develop and implements appropriate standards and practices for quality of contract manufacturing operations and ensures alignment with industry best practices.
• Ensures alignment with PQS for implementation of GxP activities with a focus on external GMP manufacturing for commercial products.
• Manages risk assessment process for CMOs and drive efforts to execute risk mitigation plans and drive continual improvement.
• Provide QA support for interdepartmental project work to ensure on-time deliverables and adherence to team resources.

Who You Are:

• BS in Pharmaceutical Engineering/Biopharmaceutical
• Minimum 5 years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences required.
• Demonstrated ability to work across matrix organization in international and multi-cultural environment.
• Experience working with external partners (e.g. contract manufacturing organizations, contract laboratories and suppliers) is preferred.
• Good understanding of external compliance trends and ability to address needs based on external demand.
• Strong knowledge of technical writing and project management skills.
• Excellent organization and presentation skills.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!