Limerick, Ireland | Posted on 11/12/2024
Industry: Pharma/Biotech/Clinical Research Work Experience: 2-3 years City: Limerick State/Province: Limerick Country: Ireland Job DescriptionAbout 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 include 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, and we provide unparalleled empowering career development through in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
RequirementsResponsibilities: Liaise with the Automation and Validation departments in an effective and timely manner as part of generating Automated System Periodic Evaluation Program (PER Program) reports.
Responsible for generating maintenance reports as part of the Maintenance program, including review and trending of work records. Liaise with multiple departments in data review and collate responses in a timely and effective manner.
Facilitate reviews and revisions of Department-related SOPs, life cycle documents, plans, and policies for each group within the Department.
Facilitate support of preventative maintenance record review and audit trail review.
Ensure report writing deadlines are met and data is concise, accurate, and meets ALCOA+ principles.
Support the department in preparation for audits with support documentation.
Support automation in the administration of equipment access.
Maintain knowledge of current good manufacturing practices (cGMPs).
Skills Required: Experience working in a regulated GxP environment.
Ability to work on own initiative, without direct supervision from management.
Team player with an ability to work well across various departments on site as well as with business partners.
Excellent written and communication skills.
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