Senior Specialist, QC Physicochemical at AstraZeneca

, , China -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP Regulations, Pharmaceutical Testing, Quality Management Systems, Physicochemical Laboratory Practices, Data Integrity, Analytical Methods, SOP Development, Quality Standards, Process Control, Validation Studies, Sampling Techniques, Trend Analysis, Communication Skills, Organization Skills, Coordination Skills, Microsoft Software

Industry

Pharmaceutical Manufacturing

Description

Major responsibilities Receive regular GMP training, regulatory training, and company role training/assessments; attend data reliability training on schedule to strengthen awareness of data reliability. Comply with company and role-related requirements; participate in establishing GMP-compliant physicochemical laboratory area management procedures and workflows and ensure normal operation of the laboratory area. Participate in drafting quality standards and SOPs for analytical methods related to physicochemical testing of materials (raw/packaging). Participate in drafting quality standards and SOPs for analytical methods related to process control, intermediates, and finished products in physicochemical testing. Participate in drafting protocols for validation and stability studies related to the Physicochemical Group and issue related reports. Be responsible for process water (steam) monitoring, including adjustments to the monitoring plan, sampling, physicochemical testing (e.g., TOC, conductivity), entrusted testing (raw water), periodic data compilation and trend analysis reporting, and maintenance of water quality standards, sampling SOPs, and monitoring procedures. Be responsible for sampling of materials (raw/excipient/packaging/consumables), physicochemical testing (e.g., osmolality, pH), entrusted testing (e.g., identification, assay), and CoA review. Support assessment and changes for new materials (raw/excipient/packaging/consumables, including GMP materials) or addition of new tests for existing materials, and execute related actions (e.g., new material SOPs and test records). Initiate, investigate, and rectify quality events related to the Physicochemical Group (deviations, OOS, changes, atypical data). Be responsible for physicochemical testing related to plasmids, lentiviral vectors, and CAR‑T; maintain and update relevant SOPs and records. Maintain inventory of reagents and consumables for the Physicochemical Group. Manage in-house prepared solutions, commercially available reagents, and consumables for the Physicochemical Group. Manage routine operation and maintenance of Physicochemical Group equipment, including support for periodic calibration, routine and annual maintenance, repair requests, equipment transfer, and support equipment addition/retirement. Complete analytical method transfer and validation for the Physicochemical Group (including drafting protocols/reports, conducting validation experiments, and investigating anomalies). Support other departments requiring assistance from the Physicochemical Group (e.g., extra sampling, quality studies, quality event investigations, contract quality agreements, supplier audits, data analysis). Ensure the authenticity and accuracy of data generated, reviewed, and provided externally. Comply with GMP (2010 Edition), “Drug Records and Data Management Requirements (Trial),” and company data integrity policies to ensure data integrity: when completing and reviewing/auditing records (electronic and paper), ensure all records and data meet ALCOA+CCEA requirements; take measures to prevent any form of data falsification; ensure data truthfulness and reliability; promptly report any data reliability issues to the supervisor or QA. Support company clinical research and regulatory submissions (including China–U.S. projects). Cooperate with internal and external audits and complete related corrective actions as required. Complete other laboratory-related tasks assigned by management on time. Perform other responsibilities as defined in quality documents. Education, Qualifications, Skills and Experience Associate degree or above in Inorganic Chemistry, Organic Chemistry, Pharmaceutical Analysis, Biology, or a related discipline. Three or more years of experience in pharmaceutical testing or pharmaceutical quality-related work. Familiar with GMP regulations and guidelines, as well as national pharmacopoeias; familiar with quality management systems. Familiar with pharmaceutical physicochemical laboratory practices and techniques, including testing of raw materials and packaging materials, testing of intermediates and finished products, and process water analyses. Proficient in computer use, including Microsoft software. Strong verbal and written communication, organization, and coordination skills, with good English listening, speaking, reading, and writing ability. Date Posted 04-1月-2026 Closing Date 30-3月-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. Regardless of role or level, we’re all connected by our purpose and drive to impact patients’ lives. As part of our Early Talent Programmes, you’ll play an integral part in living our values and helping us to deliver on this shared ambition. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Specialist will ensure compliance with GMP standards in the physicochemical laboratory, participate in drafting quality standards and SOPs, and manage physicochemical testing of materials. Responsibilities also include monitoring process water quality, initiating investigations for quality events, and supporting other departments as needed.