QA Release Associate

publiziert 22 April 2022
GehaltVerhandelbar
OrtBasel
Jobtyp Temporärstellen
DisziplinWissenschaftLife Sciences
ReferenzBBBH529348_1650639373

Jobbeschreibung



For our customer, a major player in the Pharmaceutical Industry in Basel, we are looking for a

QA Release Associate

Background:

The QA Release Associate drives and supports all processes connected with marketed products (e.g. batch release, new product launches, complaints handling and deviation management). By building a strong network with internal and external stakeholders efficient business partnering is ensured and clear communication is provided. Based on knowledge and experience, he/she assumes process ownership as assigned.
Responsibilities:

  • Follows GxP and Novartis guidelines in day-to-day work
  • Takes over (sub-) process ownership within his/her team or where assigned. The (sub-) process owner ensures the proper functioning, monitoring and continuous development of a process within Novartis and local legal requirements. Is responsible for the adequate handling of investigations and for the training of impacted employees, if required
  • Acts as Subject Matter Expert (SME) in his/her own area of responsibility
  • Supports the adequate handling and investigation of deviations including their CAPAs
  • Is responsible for maintaining and updating the quality management system within his/her area of responsibility
  • Supports readiness for all GxP regulatory inspections & audits as well as self-inspections according to plan
  • Takes over administrative and supportive tasks where required
  • Meet Key Quality Indicators (KQI) in the own area of responsibility. Assess, report and proactively monitor Key Quality Indicators in the area of responsibility, maintain overview and ensure gaps are addressed appropriately
  • Foster and champion a quality culture and a quality mindset



In the following, the main areas of responsibility are listed (not conclusive):

  • Batch Release: Responsible for coordination and preparation of the batch release
  • Returns: Responsible for coordination of returned product and preparation of documentation for the release decision
  • Narcotics: Exchange information with Health authorities related to the import of narcotics. Handles samples of narcotics according to current procedure
  • Complaints: Management of internal / external stakeholders within the complaints process (including samples management where applicable)
  • Artworks: Is responsible for QA activities related to new/changed printed packaging materials
  • Change Control (product / QA Release related): Supports QA activities for product / QA Release related change requests
  • Interaction with stakeholders: Is responsible for the interaction and communication with internal (e.g. Customer Service / Regulatory Affairs / Supply Chain Management) and external (e.g. warehouse) stakeholders within own area of responsibility
  • Check of retail authorization: Approves retail authorization information for SAP system, with focus on review of complex cases
  • Launches: For routine Launches: Represents local QA organization in the launch team, ensures QA activities for successful product launches


Key Performance Indicators

  • Performance against Key Quality Indicators in own area of responsibility.
  • Proactive identification of potential issues and implement remediation plans
  • Continuous improvement projects executed - driven by compliance and efficiency


Candidate Profile:

  • Apprenticeship in Natural Science (e.g. laboratory technician, aide in Pharmacy, bachelor degree in natural sciences) or comparable education/scientific background with experience in GxP area
  • Fluency in German and English (oral and written), French as advantage


Experience:

  • Several (3-5) years of professional experience in pharmaceutical industry, analytics, quality assurance, production, distribution or pharmacy
  • Strong interpersonal, communication, negotiation and problem solving skills
  • Skills in project management, including simplification mindset, strategic thinking and ability to implement changes



General Information:

  • Start date: 01.06.2022
  • End date: 8 months
  • Workplace: Rotkreuz
  • Workload: 80 % (2 days in Office, rest Home Office)



Your Application
Please apply online via pdf-document. For further information about the position, please contact your Kelly recruiter, Judith Atgé Martin (+41 61 270 80 16).