QA Specialist
Posted 1 day ago by Swisslinx
Negotiable
Undetermined
Undetermined
Visp, Switzerland
Summary: The QA Specialist role involves acting as a representative for Quality Assurance in project teams and meetings, addressing Drug Product QA inquiries, and supporting regulatory compliance. The position requires reviewing and approving documentation, representing QA during inspections, and contributing to continuous improvement initiatives within the Quality Management System. The specialist will also assess and approve quality records in accordance with local SOPs.
Key Responsibilities:
- Act as QA representative in Project teams and represent QA in meetings
- Act as QA contact for specific topics and realize the interface for DRs and CRs
- Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
- Support and approve risk assessments or regulatory specific risk or gap assessments.
- Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
- Represent Drug Product QA topics during regulatory inspections.
- Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
- Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
- Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.
Key Skills:
- University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
- Long-term experience working in the GMP environment of the pharmaceutical industry
- Experience working in a QA department Drug Product
- English language skills are required, German language is an advantage
Salary (Rate): undetermined
City: Visp
Country: Switzerland
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
Requirements:
Job description:
- Act as QA representative in Project teams and represent QA in meetings
- Act as QA contact for specific topics and realize the interface for DRs and CRs
- Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
- Support and approve risk assessments or regulatory specific risk or gap assessments.
- Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
- Represent Drug Product QA topics during regulatory inspections.
- Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
- Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site
- Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
- Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.
Requirements:
- University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
- Long-term experience working in the GMP environment of the pharmaceutical industry
- Experience working in a QA department Drug Product
- English language skills are required, German language is an advantage