Senior Plant Technical QA Specialist

6 days ago

Dublin, Ireland PSC Biotech Ltd Full time
Job Description

About PSC Biotech

 

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 points 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.

  

The Plant Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.



Requirements

Key Responsibilities:


  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet client and regulatory expectations.
  • Quality review and approval of Process Development and Validation documentation
  • Technical transfer documents
  • Validation Protocols, executed validation documents and reports
  • Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
  • Perform all activities in compliance with client safety standards and SOPs
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

 

Preferred Qualifications:

  • University degree. Science or Engineering related discipline preferred.
  • Understanding of principles of Validation and New Product Introduction
  • Experience in aseptic manufacturing
  • Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
  • Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  • Ability to operate across functional boundaries, both internal and external.
  • Ability to work independently and remotely with minimum direct supervision.
  • Critical thinking skills.
  • Strong organisational, communication, coordination, and meeting facilitation skills.
  • Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
  • Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

·       



#LI-KV1

Requirements
Key Responsibilities: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet client and regulatory expectations. Quality review and approval of Process Development and Validation documentation Technical transfer documents Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Perform all activities in compliance with client safety standards and SOPs In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Preferred Qualifications: University degree. Science or Engineering related discipline preferred. Understanding of principles of Validation and New Product Introduction Experience in aseptic manufacturing Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing) Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Ability to operate across functional boundaries, both internal and external. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. Strong organisational, communication, coordination, and meeting facilitation skills. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. · #LI-KV1

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