锦鲤求职岗位描述
Position Summary
This role provides QA oversight for engineering validation, process validation, and manufacturing control activities across biologics manufacturing operations. The position partners with global and site teams to ensure compliance, strengthen validation governance, and support inspection readiness across the product lifecycle.
Role Focus
QA oversight for facilities, utilities, equipment, computerized systems, and validation lifecycle activities.
QA support for process validation, manufacturing controls, and contamination prevention.
Support the development and continuous improvement of global validation procedures, templates, and standards.
Key Responsibilities
Engineering Validation QA Oversight
Provide QA oversight for qualification and validation activities related to facilities, utilities, equipment, instruments, computerized systems, and related lifecycle management.
Review key validation documents, including qualification and validation plans, protocols, reports, engineering change controls, and associated quality assessments.
Ensure validation decisions are risk-based, scientifically justified, GMP-compliant, and inspection-ready.
Manufacturing Control & Process Validation QA Oversight
Provide QA support for manufacturing control strategies, including critical process controls, in-process controls, contamination prevention, and batch execution consistency.
Review or support high-level process validation strategies, acceptance criteria, monitoring expectations, and lifecycle change impact assessments.
Assess manufacturing deviations, process excursions, atypical events, and investigation outcomes from a QA and GMP compliance perspective.
Global Standards & QMS Maintenance
Develop, maintain, and improve global validation procedures, templates, and quality standards, and assess the impact of emerging regulatory expectations where appropriate.
Compliance & Inspection Readiness
Support audit and inspection readiness for engineering validation, process validation, and manufacturing control topics.
Help ensure documentation quality, traceability, and defensible rationale for validation and manufacturing control decisions.
Cross-functional Collaboration
Partner with Validation, Engineering, Manufacturing, MSAT, QC, Site QA, and global QMS teams to align expectations and resolve quality or compliance issues.
Contribute to cross-site knowledge sharing and practical harmonization of validation and manufacturing control practices.
Minimum Requirements
Bachelor’s degree or above in Pharmaceutical Sciences, Biotechnology, Engineering, or a related discipline.
8+ years of experience in QA, Validation, Manufacturing QA, MSAT, Process Validation, or related GMP functions within the pharmaceutical or biopharmaceutical industry.
Working knowledge of GMP expectations and regulatory frameworks, including FDA, EMA, NMPA, and ICH guidelines.
Experience with validation lifecycle activities for facilities, utilities, equipment, computerized systems, or manufacturing process validation programs.
Solid understanding of operational GMP processes, including deviation management, change control, CAPA, risk management, process validation, and manufacturing control.
Good English communication skills and ability to collaborate in a global, cross-cultural environment.
Preferred Experience
Experience in biologics manufacturing, manufacturing QA, process validation, engineering validation, validation governance, or global quality system programs is highly preferred.
Familiarity with PDA Technical Reports, ISPE guidance, or similar industry practices is a plus.