Quality Control Technician

4 weeks ago

Municipal District of Carlow, Ireland PSC Biotech Corporation Full time
Job Description

About PSC Biotech

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 to 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 through 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:

  • Performs QC assignments for quality systems, processes, and controls.
  • Accountable for contribution to ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety & reliable customer supply.
  • Responds to operational and business area’s, ensuring compliance with cGMP and corporate regulations.
  • Support the performance of the site cGMP activities.
Requirements

Key Accountabilities:

  • Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
  • Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
  • Attend and successfully complete applicable CGMP training.
  • Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products.
  • Work collaboratively to ensure a safe and compliant culture.
  • Participate in driving a high-performing & inclusive culture, stimulating personal growth & development. May be required to perform other duties as assigned.

Responsible for activities including some or all of the following and any other tasks as required:

Quality

  • Liaise with the QC Leads to resolve quality-related queries where required.
  • Ensure that adequate processes and procedures are in place and followed for all Quality activities.
  • Where required, work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery, and or oversight) as required as per business needs & if needed.
  • Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
  • Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing, and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
  • Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
  • Support business-critical projects related to the Quality Department.

Delivery:

  • Responds to standard requests and communication processes to allow the flow of appropriate information between departments.
  • Use MPS principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
  • Sign approved job description.

Site Business Area Support:

  • Support in resolving routine potential quality issues. Provide quality support of controls and procedures for the end-to-end material and product lifecycle where applicable.
  • Assist team members to support the qualification/validation, technical transfers, and commercial operations at the facility where required.

Quality Control:

  • Supports the Laboratory and team members with day-to-day activities, as applicable.

Compliance Responsibilities:

  • Ensure compliance to regulatory requirements.
  • Assist team members with tasks relating to SOP's, Deviations, cleaning verification/validation data and other documents as necessary for the Quality and Manufacturing departments where required.
  • Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials, and maintenance procedures for various Quality-related systems.

Other:

  • Participate in training programs as required.

Educational and Experience Requirements:

  • Leaving Certificate or other relevant experience.

Role Reporting To: Quality Control Manager/Associate Director Quality Control

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