- Collaborate with business partners in various functions, instrument vendors, and other IT team members to implement, perform applications administration and support GxP applications and systems in a controlled laboratory, manufacturing and other regulatory functions. This includes, but not limited to maintaining GxP Systems Inventory, User Access Management - activation, modification and deactivation of users, managing user access privileges, implementation and/or retirement of GxP systems, ensuring that Backup of all GxP systems is being taken, Recovery of GxP systems when required and any other related activity assigned by IT Management through application of cGMP principles and following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements.
- Provide support during new systems implementation, overseeing design or configuration and validation (IQ / OQ/ PQ) to ensure the solutions will meet business needs while adhering to IT policies and procedures, compliance standards, and GxP requirements.
- Conduct Periodic Reviews such as but not limited to User Access Management, Systems Validation Reviews, SOP Reviews etc. to confirm computerized systems are compliant with company procedures and regulatory agency guidelines and requirements.
- Assist with QMS processes within IT, especially change control impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes.
- Propose alternate processes, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations.
- Collaborate with various stakeholders globally and/or across the sites within the region to understand and implement best GxP IT practices.
- Support regulatory, customer and other such audits from IT department.
- Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor's degree in Life
- Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management
- Excellent collaboration and communication skills.
- Ability to manage competing priorities and flexibility to shift workload when needed.
- Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
- team player with ability to work with people at all levels and diverse skill sets.
- Requires travel for up to 25%-30% of the work hours.
- Minimum 6-7+ years of hands on experience maintaining, administering GxP systems, applications, instruments and shop floor machines in a manufacturing and/or quality function with detail orientation and strong problem solving, analytical, and critical thinking skills.
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Senior Associate, IT Systems Administrator - Billerica, United States - Kaztronix
Description
Senior Associate, IT Systems Administrator
Billerica, MA
Jo b Summary
Manage day-to-day System Administration, user support and implementation of GxP Computerized Systems in QC Analytical Lab Manufacturing and other regulatory operations including, but not limited to, networked and non- networked standalone instruments, firmware based instruments, HMI's, SCADA systems and any GxP application software at any manufacturing site across the North America region.
Ar ea of Responsibility
Tr v e l Estimate
Up t o 25% to other sites within North American geography and sometimes for vendor audits
Education and Job Qualification
Experience
