QA CSV Engineer
Speichern Sie diesen Job und halten Sie Ihre Suche organisiert
Erstellen Sie ein kostenloses Konto, um Jobs zu speichern, Benachrichtigungen zu erstellen und von Ihrem Dashboard aus zu diesem Eintrag zurückzukehren.
Wenn Sie fortfahren, akzeptieren Sie unsere Nutzungsbedingungen & Datenschutzerklärung.
Purpose
- Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation.
Revised responsibilities
- Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence.
- Verify independence from authors/executors and identify unresolved GMP risks.
- Review DI controls and critical electronic-record lifecycle evidence with the DI specialists.
- Prepare QA-approved inspection narratives and coach technical SMEs; escally critical deficiencies.
- Recommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05).
Must-have requirements (recruitment)
- Substantial independent QA oversight of computerized systems in GMP (15+ years preferred; 10+ with strong oversight record flagged for D09).
- Direct FDA inspection experience (front room or back room) on computerized system or data integrity topics.
- Expert knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and data integrity guidance (FDA, MHRA, PIC/S); QA experience on OT/automation systems, preferably DeltaV.
- Willing and able to travel to Visp 2 days per month. Fluent English.
- Nice-to-have: FDA 483/warning-letter remediation, biologics manufacturing, qualified GMP auditor, German.
- CV keywords: independent QA review, FDA inspection, 483, warning letter, Part 11, Annex 11, PIC/S, MHRA DI, DeltaV, CAPA.
Critical competencies
- Independent GMP QA CSV oversight and direct FDA inspection exposure; senior profile (15+ years preferred, D09 pending).
- Expert OT computerized systems, DeltaV/batch/historian control risks, Part 11, Annex 11, GAMP 5 and DI guidance.
- Ability to challenge weak risk justifications, insufficient evidence and ineffective CAPAs.
CV screening knock-out criteria (screening w/c 19-Oct-2026)
- No direct FDA inspection exposure.
- Execution-only CSV background without an independent QA oversight role.
- Not available to start between 2-Nov-2026 and 1-Dec-2026.
Minimum deliverables
- QA review log, challenge register and disposition decisions.
- Documented review of critical validation/DI packages and inspection readiness evidence.
- Escalation log and recommended acceptance/residual-risk statements.
We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.
-
QA CSV Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz SGI Vollzeit CHF 150’000 - CHF 190’000 VertragProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Purpose Provide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. Revised responsibilities Review/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence. Verify...
-
Csv engineer
Vor 10 Stunden
oberwallis, wallis, Schweiz EFOR VollzeitCSV Engineer In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. Our ambition is to build a global leading position of our market in 2028. Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values:...
-
CSV Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz Source Group International Vollzeit CHF 120’000 - CHF 180’000 VertragPurpose Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory. Revised responsibilities Reconcile system inventory, intended use, GxP impact, ownership and validation status. Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to...
-
CSV Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz SGI Vollzeit CHF 150’000 - CHF 190’000 VertragExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.PurposeExecute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.Revised responsibilitiesReconcile system inventory, intended use, GxP impact, ownership and validation status.Develop system-specific...
-
Oberwallis, Wallis, Schweiz Source Group International Vollzeit CHF 120’000 - CHF 180’000 VertragSource Group International seeks a senior QA professional to provide independent oversight of GMP CSV activities and data integrity remediation. The role requires navigating regulatory expectations, supervising CAPA evidence, and ensuring inspection readiness for FDA-related reviews.The ideal candidate has extensive QA experience in computerized systems,...
-
Senior QA CSV Auditor for FDA-Ready DI
Vor 2 Tagen
Oberwallis, Wallis, Schweiz SGI Vollzeit CHF 150’000 - CHF 190’000 VertragSGI is seeking an experienced QA/CSV professional to provide independent GMP QA oversight of computerized systems and prepare inspection narratives. The role requires direct FDA inspection exposure, strong knowledge of Part 11, Annex 11, and DI guidance, with DeltaV familiarity and travel to Visp (2 days/month).The successful candidate will challenge risk...
-
CSV Engineer — eQMS
Vor 2 Tagen
Oberwallis, Wallis, Schweiz EFOR Vollzeit CHF 110’000 - CHF 150’000 VertragEFOR Group in Visp, Switzerland, is seeking a CSV Engineer for an on-site role to support eQMS validation from a CSV perspective. The role emphasizes adherence to CFR Part 11, GAMP5, and Data Integrity, with responsibilities across validation planning, execution, and documentation within a TrackWise-based environment.Applicants should have at least 5 years...
-
Senior GMP CSV Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz SGI Vollzeit CHF 150’000 - CHF 190’000 VertragSGI in Switzerland seeks an experienced CSV validation expert for GMP automation. You will lead risk-based validation gap assessments, develop risk analyses, and author traceability and test reports for DeltaV systems. Travel to Visp (2 days/month) and fluency in English are required.Responsibilities include executing or coordinating testing, managing...
-
QA Operations Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz Source Group International Vollzeit CHF 150’000 - CHF 180’000 VertragPurposeEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight.Revised responsibilitiesReview batch records and automation-generated batch exceptions, escalating unexplained gaps or discrepancies.Support deviations, root cause, CAPAs, change control and effectiveness checks.Conduct GMP walkdowns and assess...
-
QA Operations Engineer
Vor 2 Tagen
Oberwallis, Wallis, Schweiz SGI Vollzeit CHF 110’000 - CHF 150’000 VertragEmbed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. Purpose Embed onsite QA support into GMP shop-floor operations and automation-related batch quality oversight. Revised responsibilities Review batch records and automation-generated batch exceptions, escalating unexplained gaps or...