Job 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.
We are now looking for a Senior Analytical Chemist to join our team in City North, Ireland.
Main purpose of job:
Data Review, Technical SME, support scheduling, OOS/OOT Investigations, & drive changes and improvements in QC QMS.
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 and external clients as needed.
Actively participate in new departmental training, train and guide QC Analysts and adhere to company policy/procedures and pertinent regulatory/company requirements.
Main responsibilities:
- QC Data Review, ensure all data deemed as true results are verified and checked.
- Draft and write up COA’s
- Support routine testing with a right first-time approach with minimal out of specifications and deviations, as required
- Become technical SME and ensure cross training and support for QC Analysts
- Play an active role in technical transfer activities.
- Assist in preparation and review of technical documentation & QC Quality System documents 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.
- 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. Be customer facing as required for SME input
- 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.
- Set goals and milestones through your personal development plan liaising with management.
Additional responsibilities
- Planning and scheduling commercial product testing.
- Periodic update on tracker followed for testing
- Periodic review of resources for product testing to ensure timely delivery
- Review the lab cleaning, daily calibration, and other logbooks on daily basis to ensure all testing carried out with compliance.
- Monitoring of ongoing analysis and provide necessary support to the QC analyst
- Raising and investigating quality events related to testing
- Support for cleaning validation/Transfers whenever required
- Any other task assigned by QC Manager/Supervisor
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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