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cGMP/GLP Quality Compliant Officer

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)

QC

• 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.

QA

• 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.

Compliance

• Ensure compliance to cGMP standards by operators in aseptic processing during manufacturing.
• Carry out internal audits.

The Candidate (requirements)

1. Background in Chemical Engineering Chemistry, Life Sciences, Microbiology or Biotechnology (at least Master’s degree preferred).
2. Prior experience(s) in ISO13485 medical device and QSR compliant to FDA (21 CFR Part 820).
3. Prior experience in Pharmaceutical inspection co-operation scheme for medicinal and biologic products (PIC/S standards)
4. Prior experience with glp/ISO 17025
5. At least 6 years in regulatory bodies or in a Pic/s certified pharmaceutical company for quality lead.
6. At least 2 years’ experience in management with leadership skills for quality lead.
7. At least 3 years in regulatory bodies or pic/s certified pharmaceutical company for quality officer.
8. 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.
9. 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.
10. Familiar with sterilization and bio decontamination including material compatibility.

Interested candidates, please submit a Cover Letter and CV to [email protected].