Job Description
We are currently looking for Senior Manufacturing Analyst at our site in Westport, Co Mayo. You will be responsible for the strategy, planning, and performance of all aspects of operations and operations personnel within the Manufacturing Department to ensure compliance – FDA, HPRA, EPA, Safety, and customer requirements are met.
You will provide support to the Manufacturing Technicians IV and Manufacturing Analysts in achieving the overall business goals and objectives for the site. As part of the role, you will have the day-to-day running of the shift from the shift handover from the previous shift to the handover to the next shift by delegating the tasks accordingly.
As issues arise on shift, they are to be communicated by the Manufacturing Technicians and Analysts to the Senior Manufacturing Analyst, who in turn escalates them to the Technical Shift Lead as required. They are then responsible for re-arranging and re-assigning shift schedule / tasks / indirect reports as issues arise.
Responsibilities
Ensure team members are cross‑trained and training is progressed in a timely manner; actively participate in the training and certification of new employees.
Ensure that all aspects of the area of responsibility are fully staffed and that any constraints are managed appropriately or escalated to the Manufacturing Manager.
Ensure all activities are completed in line with regulatory (QA and EHS) and corporate requirements.
Active involvement and investigation (RCPS) of batch related non‑conformance / CAPA’s / LIRs / Complaints as they arise in the business, liaising closely with the relevant BEST Team / Micro / Packaging Team / QA team members to ensure thorough investigation is completed.
Agree with the Manufacturing Manager to develop and implement a plan for providing appropriate timely information as required.
Ensure that customer orders and requirements are met/exceeded.
Manage product improvement changes and implementation process improvements.
Lead and support Continuous Improvement initiatives as required to support the overall goals of the Manufacturing Department.
Develop, implement and maintain operational excellence methods of working within the manufacturing team in conjunction with the shift manager.
Develop and follow Senior Technicians Standard Work.
Represent the company at client and regulatory facing meetings and audits as required.
Ensure all activities of the Manufacturing Department are performed in accordance with compliance requirements, GMP, OPEX standards and relevant SOPs and policies through Process Confirmation where appropriate.
Provide leadership at the tiered OPEX meetings to ensure focus and traction is maintained on the key objectives.
Lead organizational RCPS and support technical and other RCPS sessions, this includes ownership of all operational Root Cause Problem Solving.
Coordinate with maintenance department, validations and water engineers as issues arise to ensure that they are investigated and addressed in a timely manner.
Liaise with packaging and warehouse personnel in resolving SAP batch / component related issues in a timely manner.
Lead Tier 1 meetings for the shift.
Support and ensure QMS is maintained to a high standard.
Ensure shift updates and issues are communicated, highlight any issues with schedule adherence.
Qualifications
Bachelor’s Degree in a pharmaceutical science/engineering/operations discipline.
Minimum of 3 years relevant experience in Pharma/Medical Devices/Food Operations.
Clear understanding of working within a regulated environment.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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