Process Expert
1 Year (Extendable)
Indianapolis, IN
Max PR: $42-63/hr
Job Description
Executing and coordinating validation processes including vaporized hydrogen peroxide qualification of isolators, airflow visualization studies, lifecycle changes and modifications to primary packaging, and shipping validation activities. Management contribution to Ongoing Process Verification program as well as change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with Corporate and global regulatory expectations.
Job Responsibilities
Validation:
• Support project validation planning by writing and maintaining master plans for processes, process
simulation studies, airflow visualization studies, packaging processes and ongoing verification for
processes and cleaning validation (as applicable).
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing process verification (OPV). Ensure that appropriate variables are identified for on-going monitoring as a contributor to quality risk management activities.
• Author and review process, packaging or process validation protocols & reports, ongoing process & associated reports.
• Support and hands-on execution of validation activities at the shop floor.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes
• Maintain all activities and projects under own responsibility in an inspection ready status.
• Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools. Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensure that all Site validation activities are performed and are in line with the current company requirements and cGMP, manage deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
Launch & Transfer:
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready
• Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
Key Performance Indicators (Indicate how performance for this role will be measured)
• Meet established validation milestones according to approved validation plans in accordance with overall project timeline
• Validation execution according to plan, as a measure of appropriate validation readiness activities.
• Audit and inspection outcomes as a measure of validation compliance with global regulatory expectations.
• Launches implemented on target without preventable validation related issues.
• Validation protocols executed and reports delivered according to schedule.
• Validation approach meets QM requirements, health authority and industry standards.
• Validation/annual monitoring/revalidation activities scheduled in collaboration with stakeholders to ensure that site activities continue with minimal disruption.
Education & Qualifications
Education (minimum/desirable):
• BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
Languages: Fluent in English and proficient in site local language.
Relevant Experiences:
• 4-5 years’ experience in manufacturing/ manufacturing science
and technology/technical development/quality.
• Thorough understanding of manufacturing processes and related
process equipment.
• Strong working knowledge of quality systems and regulatory
requirements across multiple health authorities.
• Experience in executing process validation.
• Expert in reviewing and writing technical reports.
• Proven project management experience in a cross-functional
environment (e.g. multi-site, technical development, other functions).
• Fundamental understanding of standard pharmaceutical analytical
testing.
• Strong autonomous worker
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