Back to Job Search

CQV Lead - Stein

  • Location: Switzerland
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 30 days ago

  • Sector: Life Sciences
  • Contact: Robin Hussain
  • Duration: 12 Months
  • Start Date: 01/08/2022
  • Expiry Date: 10 August 2022
  • Job Ref: JN -072022-472010

CQV Lead - Stein

Your Role

Supporting assigned project in Stein as CQV Lead of Filling Lines:

· Interaction with Site Operation / Site QA / SGIE-Quality

· Leading the assigned Team of Drug Product (DP) Ancillary Equipment and Lab Equipment

· Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies

· Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure

· Support / participate in validation activities during facility startup

Your Responsibilities

· Provide leadership of CQV activities in assigned Project(s) in Switzerland (together with Site Operation, Site QA, SGIE-Quality):

· Responsible for ensuring that CAPEX projects are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with Lonza's continuous improvement vision.

· Acting as subject matter expert (SME) on Lonza CQV standards

· Keeping oversight on Lonza CQV -standards, -timelines (etc.)

· Address immediate time/quality constraints and act adequately

· Force RFT thinking and approach

· Considering EHS Requirements

· Involved and support PM and Process Engineers in CQV-Planning:

· Development and delivery of CQV Documents

· Commissioning Documents (Suppliers / Process Engineers/EMR)

· QV-Documents (Suppliers / QV-Team /QA)

Your Profile

· Education: Technical degree (Bachelor's or Master's) in engineering or applied science, post graduate qualification preferred.

· Minimum of 12 years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics as well as chemical manufacturing technologies desirable.

· Significant experience in qualification of aseptic filling lines and associated equipment such as vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators

· Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.

· Fluent English is a must, Fluent in German strongly beneficial

...