Associate Quality Manager

Posted 21 December 2021
SalaryNegotiable
LocationBasel
Job type Limited
DisciplineLife SciencesQuality Assurance/Safety
ReferenceBBBH502645_1640096758

Job description

For customer a well know Pharmaceutical Company in Basel, we are looking for a

Associate Quality Manager

Job Purpose: Support the supervisor in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and supports adherence to compliance with GMP in TRD.

Responsibilities:

  • Perform review of GMP relevant documents for compliance with SOPs across several customer groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.).
  • Perform review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, GLIMS specifications).
  • Supervise 0-3 direct/indirect reports or a team.
  • Negotiate deficiencies in GMP documents with the line unit .
  • Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
  • Act as contact person for QA questions of quality relevant electronic systems (e.g. IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore), and/or as a contact person to the needs of the line unit (e.g. CoA needs from different customers; TEDI formats, etc.).
  • Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, CoCs , BRR sheets, test scripts, SOPs with extended applicability).
  • Perform statistical interpretation of trending data collected by QA (e.g. in TQW or audit database). Compile trending reports and suggest conclusions.
  • Collaborate with other associates to support the service function of QA.
  • Evaluate new QA tools (e.g. IT systems, processes)
  • Participate in knowledge exchange within and outside of TRD.
  • Participate in training and coaching of new and temporary employees in QA and from associated line functions.
  • Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.

Candidate Profile:

  • Minimum Education: Basic degree in laboratory, manufacturing or relevant discipline (e.g. apprenticeship, Bachelor or equivalent; Associates of Arts degree)
  • Desirable Education: Basic degree in scientific or relevant discipline (advanced technical college, BA/BS or equivalent)

Experience:

  • At least 5 years of experience in a corresponding line unit function (e.g. laboratory, manufacture, packaging, IT)
  • Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status.
  • Sound scientific, technical and regulatory knowledge in a specific area.
  • Detailed knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines.
  • Good knowledge of drug development .
  • Good organizational skills.
  • Proven ability to analyze and evaluate GMP compliance.
  • Knowledege and flexibility to work with relevant IT systems

Workplace: Basel

Workload: 100%

Working Time: flexible working hours

Start Date: 03.01.2021

Duration: 5 month

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).