- Perform routine testing with a right first-time approach with minimal out of specifications and deviations.
- Play an active role in technical transfer activities.
- Assist in preparation and review of technical documentation within the department as required.
- Meet testing schedule deadlines and assist other members of staff as and when required.
- Monitor and maintain laboratory inventory levels as well as prepare various logbooks for analytical and equipment usage.
- Take ownership of incoming and outgoing samples concerning different project work.
- Adapting procedures in line with the Quality Policies of the PCI organisation as appropriate to the former Millmount sites.
- Train other members of staff following company policy and procedures.
- Deputise for departmental management when required, attend meetings, and respond to internal queries as required.
- Take ownership of any training implemented by management or by the company.
- Identify, raise, progress any OOS, deviations and Capa's liaising with management and the QA department.
- Adhere to the Company's' Health & Safety policy and take initiative to identify any potential risks.
- Ensure all analytical and documented work is carried out under cGMP and GXP guidelines.
- Ensure on-going compliance with customer, regulatory and internal requirements.
- Actively participate in continuous improvement projects to maintain a high standard of testing.
- High level knowledge of commonly used wet chemistry techniques and analytical equipment.
- Dissolution/HPLC theory and maintenance.
- Good working knowledge of cGMP/GXP guidelines.
- Knowledge of ICH guidelines.
- Technical Transfer Experience.
- Experience on CDS such as Empower.
- Strong commitment to Quality Assurance principles.
- Analytical approach/attention to detail.
- Willingness to drive problem solving initiatives and to find through root cause during investigations and problem solving.
- Formally qualified to Degree level in Chemistry or related field.
- 1 - 3 years' experience within a GMP regulated pharmaceutical company.
- Received formal training in cGMP requirements from Quality Assurance.
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Analtyical Chemist
6 days ago
PCI TRGR Penn Pharmaceutical Services Ltd IrelandLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to ...
Analtyical Chemist - Stamullen, Ireland - PCI Pharma Services
Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
PCI City North Laboratory business increased significantly over the last few months, and we are now looking for an Analytical Chemist (permanent role) to manage the release and the stability sample demand.
This is a shift role covering Monday to Wednesday and Wednesday to Saturday (rotating weeks from 7am to 7pm).
As Shift Analytical Chemist you will:
Perform analytical testing in an efficient and effective manner under cGMP guidelines.
Take a lead role in method transfer activities collaborating with other PCI Pharma sites.
Actively participate in new departmental training and adhere to company policy/procedures and pertinent regulatory/company requirements.
Main responsibilities:
Additional Responsibilities/Desirable:
Qualifications/Training:
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Join us and be part of building the bridge between life changing therapies and patients.
