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Subject Matter Expert: Acceptance Procedures
Eingestellt von Edelway
Gesuchte Skills: Engineering, Sap
Projektbeschreibung
Edelway AG is a Professional Services Consultancy based in Switzerland.
One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Subject Matter Expert: Acceptance Procedures to join them on a long term basis (contract or permanent).
Languages: English & German
Rate: Excellent
Start Date: ASAP
THE ROLE:
*Oversee the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.)
*Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
*Make recommendations to achieve compliance where shortfalls are found.
*Provide Audit reports as directed.
*Perform analyze and define Inspection Plan as necessary.
*Generate Inspection Plan as necessary.
YOUR PROFILE:
*Minimum of 4 years quality planning
*A BSc in Engineering, Manufacturing or a related field
*Compliance experience in the medical device.
*Prior experience in medical device/pharmaceutical remediation preferred.
*Familiarity and interaction experience with regulatory auditing bodies preferred.
*Documented training in FDA QSR, ISO 13485/9001 required.
*Proficient in the use of spreadsheet software (Access/Excel etc.)
*Have a background in statistics and validation.
*Be willing and able to travel domestically to other EU sites as required.
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Generate DCRs/DCOs that meet the regulatory and the business requests (You will be trained on the company's system).
*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
*Good communication skills.
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
*Excellent organizational skills, readiness to take on responsibility, reliable, proactive, self-driven and customer oriented.
*Be a team player.
*Be able to manage effectively multiple priorities and tasks.
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.
One of our best clients, a global pharmaceutical company, based in the Bern/Basel area, is currently looking for a Subject Matter Expert: Acceptance Procedures to join them on a long term basis (contract or permanent).
Languages: English & German
Rate: Excellent
Start Date: ASAP
THE ROLE:
*Oversee the Core Team Leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.)
*Audit sites' inspection Plan to the standards and report out on findings (both current state and retrospectively).
*Make recommendations to achieve compliance where shortfalls are found.
*Provide Audit reports as directed.
*Perform analyze and define Inspection Plan as necessary.
*Generate Inspection Plan as necessary.
YOUR PROFILE:
*Minimum of 4 years quality planning
*A BSc in Engineering, Manufacturing or a related field
*Compliance experience in the medical device.
*Prior experience in medical device/pharmaceutical remediation preferred.
*Familiarity and interaction experience with regulatory auditing bodies preferred.
*Documented training in FDA QSR, ISO 13485/9001 required.
*Proficient in the use of spreadsheet software (Access/Excel etc.)
*Have a background in statistics and validation.
*Be willing and able to travel domestically to other EU sites as required.
*Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
*Generate DCRs/DCOs that meet the regulatory and the business requests (You will be trained on the company's system).
*Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
*Good communication skills.
*Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times.
*Excellent organizational skills, readiness to take on responsibility, reliable, proactive, self-driven and customer oriented.
*Be a team player.
*Be able to manage effectively multiple priorities and tasks.
If this sounds like your next challenge send us your CV and we will call you to discuss the role in more details.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik