To maintain the validated state of all production processes to ensure compliance with current European and Customer requirements.
To assist in all Product Transfer activities include transfers from R&D, affiliates and third party manufacturing sites.
To assist in process improvement strategies for existing formulations
To provide technical support as required within the manufacturing / QC Departments.
Maintain and coordinate the validation schedule.
Preparation of process validation protocols and reports in accordance with cGMP and customer requirements.
To assist in the timely execution of Trial and validation batches. To ensure deadlines are met and all correct sampling is carried out and all necessary records are logged.
To assist in troubleshooting of existing formulations and suggest suitable improvements and to assess and support any regulatory changes required
To assist in the transfer and scale up of products from both R&D and other manufacturing sites.
To maintain and follow all relevant SOPs
Support the implementation of the Operational Excellence Programme on the site by identifying, leading and implementing improvements.
To provide technical support as required by management
To ensure that appropriate standards of GMP are maintained in all aspects of work
To adhere to all company and legislative health, safety and environmental requirements
Participate in the quality management systems including investigations, deviations and change control, and to assist in any other duty required for the maintenance of the stability programme.
Requirements:
A science degree.
Experience on a similar role is a distinct advantage.
Excellent verbal and written communication skills
Excellent trouble shooting and problem solving skills
Good computer skills (MS Word, Excel and PowerPoint)
Good attention to detail
Ability to think logically and be proactive.
Ability to work as part of a team and on own initiative in a constructive manner
Flexible and self motivated
Package:
Minimum 6 month contract - potential to extend
Competitive rates
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
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Amgen Jobs - Dublin
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JJob Description
To maintain the validated state of all production processes to ensure compliance with current European and Customer requirements.
To assist in all Product Transfer activities include transfers from R&D, affiliates and third party manufacturing sites.
To assist in process improvement strategies for existing formulations
To provide technical support as required within the manufacturing / QC Departments.
Maintain and coordinate the validation schedule.
Preparation of process validation protocols and reports in accordance with cGMP and customer requirements.
To assist in the timely execution of Trial and validation batches. To ensure deadlines are met and all correct sampling is carried out and all necessary records are logged.
To assist in troubleshooting of existing formulations and suggest suitable improvements and to assess and support any regulatory changes required
To assist in the transfer and scale up of products from both R&D and other manufacturing sites.
To maintain and follow all relevant SOPs
Support the implementation of the Operational Excellence Programme on the site by identifying, leading and implementing improvements.
To provide technical support as required by management
To ensure that appropriate standards of GMP are maintained in all aspects of work
To adhere to all company and legislative health, safety and environmental requirements
Participate in the quality management systems including investigations, deviations and change control, and to assist in any other duty required for the maintenance of the stability programme.
Requirements:
A science degree.
Experience on a similar role is a distinct advantage.
Excellent verbal and written communication skills
Excellent trouble shooting and problem solving skills
Good computer skills (MS Word, Excel and PowerPoint)
Good attention to detail
Ability to think logically and be proactive.
Ability to work as part of a team and on own initiative in a constructive manner
Flexible and self motivated
Package:
Minimum 6 month contract - potential to extend
Competitive rates
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Amgen Jobs - Dublin
Genzyme Jobs - Waterford
J
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical