For our client, an international company in Zug, we are looking for a
Quality Associate External Quality
- Start date: ASAP
- End: 1 year
- Extension: possible
- Workplace: Zug
- Workload: 100%
Job Summary:
- Provide QA oversight support for External Manufacturer, based in Switzerland. Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (Fill-Finish activities).
- Support the External Quality account owner on tech transfers/projects as appropriate.
- Requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.
- Requires travel to the External Manufacturer site to provide cGMP assistance and quality oversight
Tasks and Responsibilities:
- Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.
- Perform review of equipment and facility qualification, environmental monitoring, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.
- Provide QA support for technology transfer and improvement of existing manufacturing processes
- Following successful tech transfer, support day-to-day quality oversight for production activities, including identification of risks, deviation and CAPA management, Complaint handling, change control, and batch documentation review.
- Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner.
- Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs
- Apply applicable GMP regulations international requirements to all aspects of the position.
- Support regulatory inspection readiness at the external manufacturer for .... products.
- Monitor trends, identify issues, recommend, and implement appropriate actions.
Must Haves:
- Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline
- Solid (5 y) knowledge of GMP, specifically:
- Aseptic manufacture (sterile, liquid dosage forms products and/or Large Molecule) experience is preferred (QA and/or production).
- Able to connect easily, team worker, able to manage across cultures.
- Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required
- Able to think outside the box and come up with solutions to problems. Open-minded for new ideas and willing to pivot when necessary.
- Strong interpersonal and written/oral communication skills
- Advanced degrees are a plus and may reduce the experience required
- Proficiency in English is a must
- Located in Switzerland (In or nearby Canton of Valais)
- Will require travel to the external Manufacturer
For our client, an international company in Zug, we are looking for a
Quality Associate External Quality
- Start date: ASAP
- End: 1 year
- Extension: possible
- Workplace: Zug
- Workload: 100%
Job Summary:
- Provide QA oversight support for External Manufacturer, based in Switzerland. Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (Fill-Finish activities).
- Support the External Quality account owner on tech transfers/projects as appropriate.
- Requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.
- Requires travel to the External Manufacturer site to provide cGMP assistance and quality oversight
Tasks and Responsibilities:
- Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.
- Perform review of equipment and facility qualification, environmental monitoring, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.
- Provide QA support for technology transfer and improvement of existing manufacturing processes
- Following successful tech transfer, support day-to-day quality oversight for production activities, including identification of risks, deviation and CAPA management, Complaint handling, change control, and batch documentation review.
- Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner.
- Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs
- Apply applicable GMP regulations international requirements to all aspects of the position.
- Support regulatory inspection readiness at the external manufacturer for .... products.
- Monitor trends, identify issues, recommend, and implement appropriate actions.
Must Haves:
- Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline
- Solid (5 y) knowledge of GMP, specifically:
- Aseptic manufacture (sterile, liquid dosage forms products and/or Large Molecule) experience is preferred (QA and/or production).
- Able to connect easily, team worker, able to manage across cultures.
- Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required
- Able to think outside the box and come up with solutions to problems. Open-minded for new ideas and willing to pivot when necessary.
- Strong interpersonal and written/oral communication skills
- Advanced degrees are a plus and may reduce the experience required
- Proficiency in English is a must
- Located in Switzerland (In or nearby Canton of Valais)
- Will require travel to the external Manufacturer
