Lab systems Administrator

Summary of role The Laboratory Systems Administrator will report to the Group Laboratory Systems Manager being primarily responsible for the day-to-day administration of all computerised laboratory systems. Key Responsibilities

• Comply with all HSE requirements including safety policies and procedures, with reference to compliance within the analytical laboratories
• Ensure safe laboratory operation
• Day to day administration of laboratory computerised systems as directed by the Group Laboratory Systems Manager
• Support QA and Analytical during regulatory and customer audits
• Support QA and Analytical during internal investigations supplying expertise in interpreting data and meta data
• Maintain systems in a compliant state
• Maintain, develop, and provide new standard operating procedures required for the compliant administration and control of laboratory systems
• Maintain system roles, responsibilities and associated records
• Carry out and document periodic system audits, including audit trails
• Develop and maintain Onboarding and off boarding of system users
• Assist in data integrity risk assessments for computerised laboratory systems
• Work with project and CSV teams to deliver and operate compliant laboratory computerised systems
• Assist in CSV activities during the introduction of new systems
• Develop and maintain procedure and records for the administration of all laboratory based computerised systems
• Perform Chromeleon CDS data audits as part of a schedule of self-inspection
• Provide assistance in identifying solutions to and completing audit actions
• Support the planning, implementation and validation of Chromeleon upgrades / maintenance updates as required
• Provide problem resolution support to system users for issues reported to the helpdesk
• Generate quality KPIs (for example, CDS Manual integration, Electronic signatures)
• Identify and develop cost saving initiatives while maintaining the highest levels of customer service, safety and compliance
• Liaises with all business areas on relevant aspects of data integrity and compliance
• Frequent contact with customers and regulators
• Liaises with Analytical Coordinators and Analysts to provide relevant training
• Frequent contact with instrument / system suppliers
• Digital services: Infrastructure, Data security, compliance and integrity
• QA / QC / R&D

Requirements

• Minimum: good honours degree in analytical science
• Good knowledge/experience of analytical instrumentation and software
• Several years analytical lab experience
• Experience in using chromatography data systems preferably Chromeleon
• Good knowledge of GxP and data integrity principles
• Good verbal and written communication skills
• Excellent IT skills

Closing Date: 18/01/2024 Why consider Sterling? Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years' experience in developing and manufacturing Active Pharmaceutical ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) R&D bioconjugation services We are a fast growing, dynamic business with facilities in the UK, US and Europe, where we employ 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients. Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal to deliver first-class science and service to our customers every day Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief Be caring. Be transparent . Be willing. Be reliable. #J-18808-Ljbffr