Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a Process Science Associate – Process Validation to join their team. This is a full time, permanent position offering an excellent salary and benefits package.
Essential Duties and Responsibilities:
Draft process validation protocols for both process performance qualification and associated studies.
Execute protocol-driven studies, analyze data and author technical reports.
Provide on-the-floor coverage during process validation campaigns.
Present data from qualification studies as required.
Performs scientific investigations (EOE & DNF).
Develops and writes protocols for manufacturing support activities.
Serves as a subject matter expert (SME) for data trending and manufacturing support activities.
Presents findings at group and possibly at interdepartmental meetings.
Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
Applies statistical process control tools in monitoring the manufacturing process.
Participates in process and quality risk assessments.
Presents process monitoring data to IOPS Management as necessary.
Assists in troubleshooting activities associated with the manufacturing process.
Supports off-site transfer activities as needed.
Reviews and/or approves Manufacturing documentation associated with the transferred process.
Education and Experience:
Requires BS/BA in Life sciences/Engineering or related field. May consider another degree discipline with relevant experience; cGMP experience is desirable.
For more information on this position please call Harmonics Recruitment on 061336136 or apply online and a member of the Harmonics team will be in touch