QC Technical Support Specialist
QC Technical Support Specialist
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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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 doentation 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 essments.
- Author/ Provide technical expertise and technical oversight of the above QC doentation.
- 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 doentation generation and investigations ociated with GMP activities.
- Author/ Provide technical expertise and technical oversight of Investigations Quality Notification Out of Process Control Limit OOPCL completion
- Be a doent system expert; this will include doent review approval and doent system work flow expedition. Format write deliver and review necessary doentation in line with the standard approval process and facilitate others to do so.
- Doents will include SOP s SWI s training doents and change controls.
- Support Laboratory activities through doentation generation filing tracking auditing and efficient maintenance of all ociated databases including the maintenance auditing and archiving of the process doentation system.
- Support Batch release through timely Investigations Quality Notification Out of Process Control Limit OOPCL completionInterim/summary report generation; meeting batch release requirements.
- Perform Compendial essments.
- Author Annual Product Review Trend Reports.
- Raise CAPAs and conduct investigations. Raise and investigate quality notifications using standard tools and ods 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 igned.
- ist in the management and/or ignment of QC training if required
Experience Knowledge & Ss:
- Proficiency in Microsoft Office and job related computer applications required with proven ytical and systematic problem solving ss
- Knowledge of regulatory/code requirements to Irish European and International Codes Standards and Practices
- Report standards policy writing ss required
- ytical od validation
- Strong influencing ss
- Flexible approach
- Effective time management and multitasking ss
- Proven organizational ss
- Excellent attention to detail
- Trouble ing ss
- 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
Support Quality Control activities in the QO laboratory through doentation generation and investigations ociated with GMP activities. Author/ Provide technical expertise and technical oversight of Investigations, Quality Notification, Out of Process Control Limit
Education
Responsible for generating and expediting review and approval processes for QC GMP doentation 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 essments. Author/ Provide technical expertise and technical oversight of the above QC doentation.
Employment Type
Full Time
