When manufacturing ensures that all departmental SOPs and MIs are followed and:
Ensure appropriate control, monitoring and delivery of activities in their area of work.
Ensure that all documentation is completed correctly, accurately in a timely manner and signed by the relevant personnel.
Carry out final documentation review and sign off to ensure documentation is right first time
Develop and coach team members and shift to success
Continuous improvement and use of appropriate lean tools
Ensure compliance to health and Safety regulations. Consistently demonstrating the behavior’s necessary to create a safe working environment for themselves and their colleagues.
Maintains the production team’s and site standards in EHS, cGMP, productivity, and costs. This includes reporting and escalation of incidents in a timely manner. To actively maintain and promote a cGMP compliant culture, ensure that the highest standards of housekeeping and safety are applied within the area in accordance with regulations and to apply the principle lean Manufacturing, problem solving, 5S, waste elimination and energy efficient activities in support and continuous improvement. Execute manufacturing-lead tasks during, equipment qualification and process validation. The tasks will be executed in accordance with the site procedures and in compliance with all safety and quality (cGMP) requirements. Participates in investigations (safety, quality, or other incidents) related to the I&P operation. Works with the various stakeholders to identify and correct the root cause and implement preventive actions to reduce the possibility of reoccurrence.
This role works with the Team Leader to resolve issues encountered while executing manufacturing tasks by providing improvement recommendations. Subsequently, this role works with other stakeholders and process operators to implement the corrective action. To maximise their individual contribution so that team objectives are achieved. To work as a team member, providing and receiving support feedback to team members and their Team Leader. To communicate and liaise with members of other teams, customers, and suppliers to meet the business’s objectives. When required to flexibly support other departments – providing adequate training is received and it is safe to do so. To suggest solutions to issues which may arise. Ensures that documentation is completed compliantly and in a timely manner. Extracts and interprets batch and system performance data e.g., SAP & GLIMS to enable timely problem solving and root cause analyses. Attend all compulsory and allocated training courses required for the role. Ensure that all training is completed in a timely manner and that personal training records are kept up to date. To continue to develop new skills, competencies, and behaviors to fulfil both current and future business needs. The role holder will be able to demonstrate the application of the skills required for their role.
Knowledge, Skills & Competencies
Previous experience in inspection or packaging of aseptic products held within a cold chain preferred
Good personal qualities and interpersonal skills such as concern for standards, integrity, communication, and discretion.
Competent in the daily use of computer systems, e.g., SAP & GLIMS
Demonstrated knowledge of cGMP (and FDA requirements a plus)
Basic mechanical aptitude or knowledge of electronic/mechanical equipment
Local language
Experience Requirements
Relevant experience and competence in cGMP and sterile product Inspection & Packaging operations in Biotech or Pharma industry preferred, ideally within Inspection and Packaging.
Experience of Groninger, Brevetti or Marchesini machines advantageous
Relevant Degree Qualification preferred
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