QC Technical Support Specialist

2 months ago

Carlow, Ireland PSC Biotech Ltd Full time
Job Description

About PSC Biotech

 

Who are we?

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:

  • Responsible for generating and expediting review and approval processes for QC GMP documentation including but not limited to Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, Standard Operating Procedures, Standard Work Instructions and change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit events,
  • Compendial Assessments. 
  • Author/ Provide technical expertise and technical oversight of the above QC documentation.
  • Ensure that objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety, and reliable supply to our customers.

Requirements

Role Functions:

  • Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities.
  • Author/ Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit OOPCL completion
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
  • Documents will include SOP’s, SWI’s, training documents, and change controls.
  • Support Laboratory activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Investigations, Quality Notification, Out of Process Control Limit OOPCL completion,Interim/summary report generation; meeting batch release requirements.
  • Perform Compendial Assessments.
  • Author Annual Product Review, Trend Reports.
  • Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Required to comply with client’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of QC training if required

 

Experience, Knowledge & Skills:

  • Proficiency in Microsoft Office and job related computer applications required with proven analytical and systematic problem solving skills
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Analytical Method validation
  • Strong influencing skills
  • Flexible approach
  • Effective time management and multi-tasking skills
  • Proven organizational skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Goal/results orientated

 

Qualifications & Education:

  • Bachelor’s Degree or higher preferred; ideally in a Science, or other Technical discipline
  • Relevant experience in QC Laboratory within GMP setting

 

 

 

 



Requirements
Support Quality Control activities in the QO laboratory through documentation generation and investigations associated with GMP activities. Author/ Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit

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