Batch Record Specialist (m/f)

REFERENZNUMMER:

262708/11

IHRE AUFGABEN:

-Prepare and review documentations for batch record review process
-Resolve deviations from batch record by collaborating with the contract manufacturer
-Create and/or modify Quality Agreements supporting internal collaborations
-Review current processes, manage gap analysis process and provide solutions
-Provide support in project management of initiatives for process improvement cross-functionally
-Compile and report on monthly data for general Quality issues at contract manufacturing sites
-Create required presentations and support Quality review meetings
-Cooperate with team members in identifying, managing and communicating project risks and risk management strategies

IHRE QUALIFIKATIONEN:

-University degree in Pharmacy, Biology, Chemistry, Chemical Engineering or Biochemistry
-Proven knowledge of Pharma GMPs, health authority regulations and other international standards
-Demonstrated knowledge and execution of Quality operations and processes
-Profound working experience in Quality with experience in a Quality function in packaging operations
-Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with key stakeholders

WEITERE QUALIFIKATIONEN:

Quality manager