AstraZeneca
Pharmaceutical
SeniorSpecialist,QCPhysicochemical
“Senior Specialist, QC Physicochemical at AstraZeneca. Skills: Physicochemical testing, GMP regulations, Quality management systems. Receive GMP, regulatory, and company training. Comply with company procedures”
What You'll Achieve.
Strengthen awareness of data reliability; Ensure normal operation of the laboratory area; Ensure data integrity; Prevent any form of data falsification; Promptly report any data reliability issues
Industry & Context.
Investigate and rectify quality events; Investigate anomalies; Problem-solving
What They're Looking For.
Must Have
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, Familiar with quality management systems, Familiar with pharmaceutical physicochemical laboratory practices and techniques, Proficient in computer use, including Microsoft software, Good English listening, speaking, reading, and writing ability
Nice to Have
Familiar with national regulations, Testing of raw materials and packaging materials, Testing of intermediates and finished products, Process water analyses, Verbal and written communication skills, Organization skills, Coordination skills
What You'll Do.
Comply with company procedures
Establish GMP-compliant laboratory procedures
Draft quality standards and SOPs
Draft analytical methods SOPs
Draft validation and stability protocols
Monitor process water
Perform physicochemical testing
Support new material assessment
Investigate and rectify quality events
Perform physicochemical testing for plasmids
Maintain inventory of reagents and consumables
Manage in-house prepared solutions
Manage commercially available reagents
Manage routine operation and maintenance of equipment
Complete analytical method transfer and validation
Support other departments
Ensure authenticity and accuracy of data
Comply with data integrity policies
Support company clinical research
Support regulatory submissions
Cooperate with internal and external audits
Complete laboratory-related tasks
How You'll Work.
Team & Collaboration
Support other departments requiring assistance; Cooperate with internal and external audits
Communication Scope
Verbal communication; Written communication; English listening; English speaking; English reading; English writing
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