BDS Manufacturing Support Specialist
Pharmaceutical
BDSManufacturingSupportSpecialist12monthFTC
“BDS Manufacturing Support Specialist - 12 month FTC at BDS Manufacturing Support Specialist. Skills: operational support activities, documentation, investigations, changes, improvement projects, compliance, technical writing, Good Manufacturing Practice deviations, structured problem solving, CAPA’s, change controls, supplier issues, risk assessments, inspection readiness, audits, health authority inspections, metrics. Perform technical writing to create and edit documents ( batch records, SOPs,”
What You'll Achieve.
ensure appropriate and proactive improvements are implemented; meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements; Collate routine metrics
Industry & Context.
problem-solving; structured problem solving
What They're Looking For.
Must Have
Minimum of 2 years’ experience in Manufacturing Operations in a Pharmaceutical or Biopharmaceutical company, Good knowledge of GMP/HPRA/FDA regulatory requirements, technical writing skills, Self-starter with communication, problem-solving and presentation skills, Ability to work effectively in the cross-functional environment as well as independently on a consistent basis, Work collaboratively in a matrix environment, Proven ability to work well as part of a team and on own with minimum supervision
Nice to Have
BSc or MSc in Chemical Engineering, Bioscience, or Biotechnology
What You'll Do.
Perform technical writing to create and edit documents ( batch records
Work Instructions etc) to support Biopharmaceutical Manufacturing Operations
author and co-ordination of Good Manufacturing Practice deviations through the quality management system
Actively monitor and trend investigation and error topics to ensure appropriate and proactive improvements are implemented
own and participate in change controls while meeting the regulatory requirements defined in relevant health authority submissions
cGMPs and local Health and Safety requirements
Ownership of Operations related supplier issues
own and drive improvement projects for the BDS facility and its supporting processes and functions
Participate and/or lead risk assessments
Participate in inspection readiness projects and support internal audits and health authority inspections
Collate routine metrics
How You'll Work.
Team & Collaboration
key interface between the shift operations teams and day-based cross functional support; Ability to work effectively in the cross-functional environment; Work collaboratively in a matrix environment; Proven ability to work well as part of a team
Communication Scope
communication; presentation skills
Process & Methodology
improvement projects
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