- Lead a team of analysts in QC Chemistry by coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant SOPs
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements
- Ensure relevant assays are performed on samples in support of release test and stability test programs, including but not limited to: HPLC, UV, iclEF (lmaged Capillary isoelectric focusing), and Compendial assays
- Support any validation and qualification of test methods and processes as required
- Ensure audit readiness at all time
- Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation.
- Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
- Facilitate laboratory investigations and support associated investigationsTroubleshoot laboratory methods and instrument problems.
- Represent the QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits.
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed within the specified lead-time
- B.A. / B.Sc. or equivalent in Chemistry or other biotechnical science or equivalent experience in regulated industry.
- Minimum 8 years of laboratory experience in a GMP laboratory
- Proven ability to work in a matrixed organization.
- Proven communication skills including providing communication to higher level management.
- Good knowledge of current regulatory requirements for QC
- Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
- Excellent problem solving and root cause analysis skills.
- Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
- Strong organizational skills.
- Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate
- Excellent written and oral communication skills.
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QC Chemistry Supervisor - Dublin, Ireland - Alexion Pharmaceuticals
Description
This is what you will do:
The QC Supervisor will support the QC Chemistry team. They will oversee the operation of a QC testing group by means of a hands on approach to laboratory operations and supervise a team of analysts. The supervisor will provide technical support with regard to method validation, method transfer, regulatory updates and new technology as required.
You will be responsible for:
You will need to have:
We would prefer for you to have:
Date Posted
23-Apr-2024Closing Date
27-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
