Bulk Operations Manufacturing Manager

vor 4 Wochen

ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Job Summary

As a key player in the product manufacturing process, this position will work closely with QA, QC, production, and logistics departments to ensure that packaging goods are produced according to supply needs and as per the highest standards of quality and health & safety.

Responsibilities
  • Manage the daily operations of the Bulk team, including planning, communication, team organization, control, and monitoring of defined targets to ensure delivery on time.
  • Develop and implement strategies for the Bulk Operations team, including resource planning, gap assessment, and succession planning.
  • Lead corrective actions and improvement initiatives within the Bulk Operations Department.
  • Ensure compliance with GMP regulations and ensure that KPIs of Bulk Operations activities are defined and met as per targets.
  • Manage the bulk operations planning compared to the logistics request to ensure delivery on time.
  • Lead site-related cross-functional projects and act as SME in cross-functional/multi-site projects.
  • Propose, sponsor, and manage investment, improvement, and evolution projects.
  • Support the manufacturing head to establish and follow the bulk budget.
  • Ensure traceability and compliance of operations carried out by the team.
  • Ensure training conformity of Bulk team for primary/secondary and manual activities.
  • Conduct investigations into Bulk failures, develop, and implement remediation plans.
  • Ensure Bulk representation during health authorities audit and internal audit.
  • Define, control, and maintain all pre-establish documentation to ensure traceability of operations carried out.
  • Draft Standard Operating Procedure and working procedure linked to the area of responsibility.
  • Conform to the directives and instructions defined in the pharmaceutical site quality system and EHS.
  • Apply risk management techniques and/or participate to risk assessment/analysis group linked to packaging process.
Qualifications

Experience/Education

  • Master Science degree
  • > 5 years of previous experience in pharmaceutical industry, ideally in bulk GMP activities
  • > 3 years of management of GMP activities and people

Knowledge/Skills/Abilities:

  • Strong working knowledge to ensure Bulk activities compliance with applicable regulations i.e. cGMP, FDA regulation
  • Fluent in French and English
  • Organized and rigorous, able to provide leadership and coaching to the bulk team in order to maintain an environment of trust and personal accountable
  • Demonstrated ability to effectively communicate with the team but also at all levels of the organizations
  • Ability to take decision
  • Technical skills to apply LEAN approaches.
  • Autonomous and aptitude to work on the ground
  • Quality and integrity oriented
  • High level of computer literacy (MS office, Excel)

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