QA Senior Specialist
About the job
Reporting to the Senior Manager, QA Laboratory Operations the QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations. The role will support the centralized EU based Global Biologics Laboratory performing commercial finished product testing and release activities. The QA Senior Specialist will also provide quality oversight for internal equipment qualification, method transfer activities, and QC site operations for the manufacture of biologics drug substance.
Key Responsibilities
* QA review and approval activities for:
o Laboratory investigations and deviations and associated corrective actions.
o Contract testing laboratories investigations and associated documentation
o Operational SOPs, test methods, forms and directives
o Annual product reviews
o Trending reports
o Laboratory equipment/instrument qualification protocols and reports
o Protocols and reports for method validations and technical transfers
o Change controls
* Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and
Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents
and regulatory requirements.
* Supporting the QC laboratory through global regulatory agency inspections and achievement of market
approvals.
* Supporting the execution of the internal audit program.
* Supporting QC and QA Network Harmonisation initiatives.
Qualifications & Experience
* Minimum of a BSc in Science or related discipline
* Minimum of 3 years Quality experience in the biopharmaceutical industry
* A thorough understanding of cGMP requirements for laboratory compliance including equipment and
instrumentation qualification requirements is essential.
* Excellent written and verbal communication skills
* Ability to work on his/her own initiative in addition to working as part of a team
* Ability to work across a team matrix in order to meet accelerated timelines
* Excellent time management & organisational skills along with a proven ability to multi-task
