Calibration Technician at Aspen Pharma Group

Overview

•  Responsible for internal and external calibrations of equipment and machinery in PE facility
•  Repair and maintain calibration equipment according to standards
•  Ensure continuous availability and functioning of production systems, adhering to GMP and safety requirements
•  Continuous improvement in calibration methods and test equipment
•  Perform internal audits and act as representative during auditing

Responsibilities

Planning and Operational Support

•  Act as a technical/ subject matter resource
•  Facilitate implementation of current processes, including training of staff on SOPs and maintenance of equipment/ machinery
•  Identify shortcomings and provide input into changes or improvements to policies, processes, tools and techniques

Equipment Maintenance and Calibration

•  Update and maintain calibration schedule/ maintenance programme
•  Identify opportunities to conduct in-house calibration
•  Implement initiatives and projects to expand in-house accredited calibration competence and service
•  Repair and conduct preventative maintenance on equipment according to standards, job cards and maintenance schedule
•  Calibrate equipment and machines according to standards and calibration schedule
•  Monitor calibration of equipment by external service providers
•  Manage and attend to call-outs for machine/ equipment breakdowns
•  Complete and record job cards in system as required/ per call-out
•  Report calibration deviations and equipment/ instrument failures
•  Compile and update route maintenance according to Pragma
•  Review job cards to identify trends and corrective actions for continuous improvement
•  Recommend changes to maintenance and calibration procedures, methods and test equipment
•  Develop, review and implement SOPs for equipment used for calibration

Calibration Audits

•  Perform planned calibration inspections and tasks according to internal audit calibration schedule
•  Represent calibration in external audits

Reporting and record-keeping

•  Gather information required for reporting and report on deliverables
•  Complete and consolidate standard documents
•  Document and file data according to SOPs and regulation
•  Update and maintain records and systems
•  Retrieve supporting documentation and records to facilitate and support query resolution

Requirements
Background/experience

•  Trade Tested Electrician with 2 to 4 years’ post Apprenticeship experience as an Electrician

Specific job skills

•  Comprehensive knowledge of mechanical and electric repair and maintenance of Pharmaceutical calibration equipment
•  Knowledge of computerised maintenance systems (Pragma) would be an advantage
•  Understanding of pharmaceutical manufacturing, standards and compliance requirements
•  Physically capable of lifting/ moving heavy equipment
•  Ability to interpret and implement policies, processes and objectives

Competencies

•  Information Gathering
•  Interrogating Information
•  Pragmatic Action
•  Meeting Deadlines
•  Finalising Outputs
•  Maintaining Accuracy

Accountability & Decision Rights

•  Apply advanced competencies and skills, comprehensive knowledge of technical, quality and regulatory standards
•  Independently resolve issues and complex matters