Mes recipe author

London  ‐ Remote
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Keywords

SAP Applications Application Programming Interfaces (APIs) Good Manufacturing Practices Quality Management Technical Acumen Safety Principles Innovation Technical Support Chemistry Automation Batch Processing Business Continuity Business Process Improvement Technical Analysis Performance Management Food Safety Governance Maintenance Manufacturing Pharmaceuticals Production Systems Regulatory Requirements Manufacturing Processes

Description

Mes Author to work for a Pharmaceutical company

The role is as follows
Mes Author role
Remote - There is a chance of 2 weeks onsite anywhere in the world (this will be fully expensed)
Outside ir35
Rate - TBC
1 stage interview process next week
Start - Late June/Early July
6 months contract

Purpose:
-To maintain the POMSnet environment; to author & maintain recipes & worksheets for API & DP manufacturing; and also author and maintain the recipes & BOMs in SAP.
- To operate as a team member within the MES team in the implementation and maintenance of the MES & SAP system for the API & DP buildings.

Responsibilities:
  • Liaise with Manufacturing and Quality to close out MES execution exceptions.
  • Troubleshoot and provide solutions for all MES & SAP problems in recipe execution and recipe authoring.
  • Liaise with quality to provide approved documentation for all MES system changes.
  • Design, create, write and execute system and test documentation to a high quality standard.
  • Design, create, write and/or make all required changes to MES & SAP Recipes, worksheets, equipment and material spec's including phase transition logic to a high
    quality standard.
  • Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures (CIs, CIRs, MIs, MIRs and SOPs) are aligned to MES processes and vice versa.
  • Design, create, write and provide training for all other site personnel on their related MES roles.
  • Participate in MES knowledge exchanges, MES Governance meetings, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified.
  • Work closely with IT regarding upgrades, patching, hardware support, security and system access.
  • Liaise with GMES on Sligo required system improvements.
  • Provide support to other MES system users as required to ensure business continuity.
  • Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration.
  • Keep other recipe authors up to date on MES changes.
  • Documentation of all activities in line with cGMP requirements.
  • Cross training within the team and training of new team members.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Adheres to and supports all EHS & E standards, procedures and policies.

Supervision Received
-The position will report directly to the Global process owner,
- Goals are reviewed on a regular basis and formal performance reviews are carried out once per year.

Supervision Provided
- No direct reports.
- Maintains regular contact with support functions on site.

Qualifications:
Diploma qualification in suitable science/engineering course and/or suitable experience.

Job/Technical Skills
  • A minimum of 5 years' experience in Batch processing operations in an FDA/HPRA regulated industry.
  • Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
  • Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role.
  • A good knowledge of IT systems/MES is required for this role.

Cognitive/Business Skills
  • The position requires a high level of attention to detail and mental concentration, to ensure total compliance with procedures at all times.
  • The position requires proven problem solving skills, and the ability to adapt to new manufacturing process on a regular basis.
  • The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times.
  • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
  • Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
  • Requires total commitment to quality and maintaining a high standard of work at all times.
  • Demonstrates the highest levels of integrity and a strong work ethic at all times.
  • Strong communication skills both verbal and written are required for the execution of this role.
  • Strong interpersonal skills are required.
  • Understands and Supports the principles of Perfect Performance.

Ownership/Accountability
  • This position is responsible for ensuring the smooth running of the MES system and ensuring availability to manufacturing at all times.
  • The position has a high level of autonomy and individuals are expected to work on their own initiative.
  • Shows a high level of tenacity to ensure closure of issues.
  • This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned.
  • Demonstrates an ethos of Right First Time at all times.
  • Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
Start date
ASAP
Duration
6 months
From
Opus Recruitment Solutions Ltd
Published at
13.05.2024
Project ID:
2749481
Contract type
Freelance
Workplace
100 % remote
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