Technical Administrative Assistant

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 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. Role Description: Responsible for providing comprehensive administrative support to global technical organisation to ensure objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety and reliable supply to our customers. Requirements Role Functions: Provide effective administrative support for a technical team of individual contributors and managers to facilitate efficient operations, thereby facilitate operational/technical team members to concentrate on production/Technical specific value added tasks, acting as point of contact as appropriate.   May include tasks such as conducting research, analyzing and reviewing data, and recommending action. Establish and effectively manage information management systems, develop reports, presentations, projects, timelines and correspondence utilizing many different computerized systems. Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software for expenses management, travel management, document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc Coordinate special projects/events within the area/division across sites. Support Leadership activities including selection, development, coaching and day to day management. Active participation in the Tier process in preparing and running reports on MyLearning, Trackwise, QN/CAPA’s, GMP Permits, Entropy and Site Action Register items. Responsible for the maintenance and /or support for Technical Document System to include the assignment of document numbers, archival of documents and auditing of the document log.   The document log and action log are audited on a quarterly basis to ensure the information in it is up-to-date and that documents are completed, cancelled or extended by the assigned due date. Support Technical Engineering to be audit ready.   Act as Audit Scribe for internal Corporate Audits, work with audit team and manage back room compiling required documentation, defining its agenda, scope and purpose and assisting with general audit preparation. Complete department specific assignments; including SOP administration, co-ordination of training, information repository co-ordination and compliance, co-ordination of regulatory inspections, maintenance and communication of department schedules, stationery par levels. Act as Teamspace Administrator for the Client Site, which entails creating individual accounts to granting access, developing web pages, creating folders and adding document links on individual requests. Required to comply with client 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 across the organisation May be required to perform other duties as assigned.   Experience, Knowledge & Skills: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Understand the specific responsibilities of groups within the organisation departments as they relate to ones own Proficiency in Microsoft Office and job related computer applications required. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required. Understanding of Lean Six Sigma Methodology preferred department, understanding the business processes ones department supports Customer service Diary management Vendor liaison Self motivated Flexible approach Proven organizational skills Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills Goal/results orientated Data analysis Training skills   Qualifications & Education: Typical Minimum Education: Leaving Cert or higher preferred; ideally in a related discipline #LI-XA1 Requirements Role Functions: Provide effective administrative support for a technical team of individual contributors and managers to facilitate efficient operations, thereby facilitate operational/technical team members to concentrate on production/Technical specific value added tasks, acting as point of contact as appropriate. May include tasks such as conducting research, analyzing and reviewing data, and recommending action. Establish and effectively manage information management systems, develop reports, presentations, projects, timelines and correspondence utilizing many different computerized systems. Use standard systems including MS Word, Excel, PowerPoint, Outlook, SAP and various company and industry specific software for expenses management, travel management, document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc Coordinate special projects/events within the area/division across sites. Support Leadership activities including selection, development, coaching and day to day management. Active participation in the Tier process in preparing and running reports on MyLearning, Trackwise, QN/CAPA’s, GMP Permits, Entropy and Site Action Register items. Responsible for the maintenance and /or support for Technical Document System to include the assignment of document numbers, archival of documents and auditing of the document log. The document log and action log are audited on a quarterly basis to ensure the information in it is up-to-date and that documents are completed, cancelled or extended by the assigned due date. Support Technical Engineering to be audit ready. Act as Audit Scribe for internal Corporate Audits, work with audit team and manage back room compiling required documentation, defining its agenda, scope and purpose and assisting with general audit preparation. Complete department specific assignments; including SOP administration, co-ordination of training, information repository co-ordination and compliance, co-ordination of regulatory inspections, maintenance and communication of department schedules, stationery par levels. Act as Teamspace Administrator for the Client Site, which entails creating individual accounts to granting access, developing web pages, creating folders and adding document links on individual requests. Required to comply with client 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 across the organisation May be required to perform other duties as assigned. Experience, Knowledge & Skills: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Understand the specific responsibilities of groups within the organisation departments as they relate to ones own Proficiency in Microsoft Office and job related computer applications required. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required. Understanding of Lean Six Sigma Methodology preferred department, understanding the business processes ones department supports Customer service Diary management Vendor liaison Self motivated Flexible approach Proven organizational skills Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills Goal/results orientated Data analysis Training skills Qualifications & Education: Typical Minimum Education: Leaving Cert or higher preferred; ideally in a related discipline #LI-XA1