cGMP/GLP Quality Lead/Manager
Esco Aster is looking to add to our quality department for both, QC, IPQC and QA to ensure compliance to cGMP for Pic/s, Eu for ATMP and FDA standards for cell- gene- and tissue engineering.
The Role (daily responsibilities)
- Establish and improve documentations for the quality control system (including DQ/ IQ/ OQ /PQ) required by QMS based on Vtm.
- Standard management (raw materials, products)
- Supervise analytical process
- Manage quality risk via risk assessment.
- Establish PAT (Process Analytical Techniques)
- Incoming goods QC for storage, quarantine and release.
- Establish sterility testing to USP standards.
- Supplier management for raw material suppliers (audit)
- Accommodate authority and customer audits
- Promote Self-checks (internal audits, QA patrols)
- Manage quality information (complaints)
- Develop and execute environmental monitoring for viable and non-viable and sampling plan.
- Manage regulatory filings submission and dossier (including, the acquisition/ changeover management/ maintain or renew licenses including GMP for Pharmaceutical manufacturing, medical device manufacturing, GMP for food products, Halal, HACCP), cosmetics, HBRA (Human Biological Research Act) and Healthcare Services Act (HCSA)
- validate aseptic gowning on operators
- validate media fills for aseptic filling including optional lyophilization.
- validate cleaning and disinfectant reagents.
- familiar with USP and Pda standards on single use, extractables and leachables.
- Ensure compliance to cGMP standards by operators in aseptic processing during manufacturing.
- Carry out internal audits.
The Candidate (requirements)
- Background in Chemical Engineering Chemistry, Life Sciences, Microbiology or Biotechnology (at least Master’s degree preferred).
- Prior experience(s) in ISO13485 medical device and QSR compliant to FDA (21 CFR Part 820).
- Prior experience in Pharmaceutical inspection co-operation scheme for medicinal and biologic products (PIC/S standards)
- Prior experience with glp/ISO 17025
- At least 6 years in regulatory bodies or in a Pic/s certified pharmaceutical company for quality lead.
- At least 2 years’ experience in management with leadership skills for quality lead.
- At least 3 years in regulatory bodies or pic/s certified pharmaceutical company for quality officer.
- At least 6 years with cleanroom, facility and validation of advanced aseptic processing equipment including bioreactors, fermenters, isolators, filling lines, freeze dryers, autoclaves, AHU, utilities for validation manager.
- At least 10 years in regulatory bodies or pic/s certified pharmaceutical company for quality officer and 4 years’ experience in management with leadership skills for quality lead.
- Familiar with sterilization and bio decontamination including material compatibility.