Biopharmaceutical Quality Expert
Posted on Apr 5, 2021 by CTG
Provides technical support for clinical batch manufacturing which includes reviewing clinical batch production documents, providing QA evaluation of discrepancies Support implementation of respective global Quality initiatives, programs and regulations
Independently reviews, revises and approves clinical batch production documents (eg master batch records, Clinical Manufacture Facilitys operational SOP, Change controls, Deviations etc.) and provides QA evaluation of discrepancies offering sound suggestions on improvement.
Trains internal customers/stakeholders on QAD relevant activities.
Supports internal and external inspections and audits.
Revises SOPs or other QA & Compliance documents.
Signs Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP).in
Reviews and approves manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan.
Required Experience and Skills:
Bachelor's degree in a scientific/technical discipline related to biology, biotechnology, chemistry or pharmaceutics.
6+ years of related experience in the biopharmaceutical industry with an emphasis in Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience.
4 years of relevant experience in the biopharmaceutical industry with an emphasis in Clinical Manufacturing lot release in a GMP regulated industry.
Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs.
Previous work experience in a Clinical manufacturing setting
General understanding of drug development process R & D area
Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.
Proficiency in IT systems and software, eg, MS Office and SAP