Quality Assurance Specialist - Switzerland

☞ PSC Biotech Corporation

見る: 157

更新日: 25-04-2024

場所: Visp Valais VS

カテゴリー: 品質保証/品質管理

業界: Biotechnology

レベル: Entry level

ジョブタイプ: Full-time

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仕事内容

About PSC Biotech Ltd




Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview

We are looking for a Batch Record Reviewer to extend our team. You will report to the QA Operations Team lead, work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within QA.

We are looking for someone to be based/relocate to Switzerland with full right to work in Switzerland.

Requirements

Key responsibilities

  • Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
  • Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations.
  • Ensure shop floor QA oversight is a must (20%).
  • Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.
  • Author, Review and approve GMP-relevant documents and SOPs.
  • Responsible to present Drug Product QA Operations or support with other SMEs topics during the conduction of all customer audits, internal audits and regulatory inspections within DPS / Biologics /
  • Provide GXP-related trainings to Module D Operations personnel (eg. GMP, Good Documentation Practice,…).
  • Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.
  • Review and release product specific documentation such as process descriptions, recipes, manufacturing batch records, etc.
  • Review and approve executed batch records , prepare batch release for the responsible person (FvP), including recommendation on disposition status.
  • Support continuous improvement programs to establish an effective Quality Management System for DPS .
  • Interact with customers for QA operations topics such as SOPs, change controls, deviations, complaints and others.

Key Requirements

  • Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field.
  • Previous experience in GMP regulated pharmaceutical / API industry is an advantage.
  • Ability to identify non-compliance and gaps from quality standards.
  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
  • Full proficiency in English is a must, German or additional languages are a plus.

#LI- AM1
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締切: 09-06-2024

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