Cleaning Validation Specialist Ireland

3 semanas atrás


São Paulo, São Paulo, Brasil PSC Biotech Corporation Tempo inteiro
About PSC Biotech Corporation

PSC Biotech Corporation is a leading biotech consultancy firm with a global presence. Our company was founded in 1996 and has since grown to serve over 350 clients in more than 23 countries worldwide.

Job Description

We are seeking a highly skilled Vaccines IPT Technical Support Specialist to join our team. The successful candidate will provide validation and technical support to our Vaccines IPT team, ensuring the highest quality and compliance standards.

Key Responsibilities
  • Execute cleaning cycle development and PQ of equipment
  • Write and adhere to validation strategies, coordinate with outside vendors, write protocols independently, sample submission, analyze test results, and prepare technical reports
  • Execute run the business activities, e.g., equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments
  • Provide support during commissioning phase by reviewing and approving documents, ensuring documentation complies with standards
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
  • Technical report writing, statistical analysis of data
  • Adhere to the latest regulatory guidelines
  • Represent the IPT on cross-functional project teams
  • Provide technical input and support and present as an SME on relevant topics during regulatory inspections
  • Adhere to highest standards for Compliance (Quality and Safety)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant
Requirements
  • 3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering
  • A working knowledge of the GxP systems associated with this role would be advantageous


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