Quality Assurance Manager | Jobs Neuchâtel
03 August 2022
Category
Life Sciences
Job Reference Number
JN-062022-313329
KANTON
Neuchâtel

Our Client is a pharmaceutical company

Reporting to the site Director and functionally to the QA Corporate Director, the Quality Assurance Manager is responsible for the Company's Quality System.

Your Responsibilities

  • Measuring and improving the QA performance according to the relevant KPIs
  • Managing and overseeing all QA activities including validations, qualifications, Execution of batch record review, validation, qualification of equipment utilities and machines, Deviation, complaints and Change Control management, Supplier qualification for finished and semi-finished products, materials, raw materials and their periodic requalification …etc.
  • Leading and developing the existing QA Team
  • Implementing the policy of Quality Assurance according to Corporate QA guidelines
  • Defining SOPs (Standard Operating Procedures) and GMP-related documentation along with other involved units/ department Managers and secure compliance with GMP
  • Analysis and evaluation of monitoring data and key performances indexes in order to insure a continuous improvement of the quality system
  • Quality investigations and definition of corrective and preventive actions
  • Issuance of Master Batch Records, validation and qualification protocols, reports and GMP related documents (risk analysis, technical reports, etc.)
  • Managing self-inspection and third parties' inspections
  • Assuring that all QA Activities are performed in time and in accordance to finished product release processes
  • Carrying on controls and audits of the internal Quality system

Your Profile

  • Master/Doctor's degree in Pharmacy, in Chemistry, Engineering, or related technical science disciplines
  • Over 8 - 12 years' experience - with successful team management - within the pharmaceutical industry, in QA or Production, preferably gained in small-medium Pharmaceuticals with marketing authorization (GMP certificated) released by local Health authorities (FDA, Swissmedic,…)
  • Expertise in injectable aseptically filled products (manufacturing) and terminally sterilized products will be a must, together with excellent knowledge and expertise in pharmaceutical GMP procedures
  • Excellent knowledge of English, verbal and written. Fluent in French.  
  • Strong management and leadership skills to lead and motivate the team
  • Organizational capabilities
  • Excellent relational and communication skills, keen to collaborate proactively
  • Pragmatic and with a problem-solving attitude
  • Strong commitment to continuous improvement

#BOOST Permanent Contract