- Reference: CJ46513
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
- Liaise with Technical Development, Quality Control or Process team members to identify priorities. Communicate requirements to the AD group or Senior AD Chemist
- Carry out routine analysis including sample validation peer review/approval of AD samples.
- Prepare and issue AD reports detailing the background, investigation and conclusion of quality issues, as required
Laboratory GMP Compliance
- Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures
- Maintain laboratory notebooks and proforma testing sheets
- Carry out calibration of equipment and analytical balances as required.
- Ensure that the validation/calibration documentation associated with instrumentation is appropriately signed off before use
Analytical Method Development and Validation
- Carry out development/optimisation of new or established analytical methods
- Perform validation of new analytical methods, periodic method validation reviews, issuing or upgrading validation reports in line with current Regulatory expectations
- Participate in the validation of analytical methods, as requested. Typically, method equivalency, as per an agreed protocol or Measurement Systems Analysis (MSA)
Technical Support or Troubleshooting for Existing Products
- Provide technical data/opinion to both internal and external customers where required
- Participate in cross-functional meetings/teleconferences (internal and external) as appropriate, including regulatory meetings
- Participate in Quality Investigation Process as required
New Product Technology Transfer
- Attend and participate in technology transfer cross-functional and analytical technology transfer meetings
- Obtain details of method/equipment requirements (including reference standards) to allow bench evaluations to be carried out.
- Create, update analytical methods and specifications as appropriate.
- Obtain analytical handover package, perform gap analysis and obtain missing documents/ data from sponsoring site
- Provide bench and technical support to the validation campaign.
- Prepare analytical documentation for regulatory filing
Senior Analytical Development Chemist Designate
- Ensure that the AD group metrics are achieved through performance management
- Manage and prioritise the activities of the AD group
- Prepare and support the AD lab for internal and external audits
- Promote good laboratory GMP within the laboratory.
- Approval of AD and Buying sample reports
Decision Making and Problem-Solving Ability
- Ability to make key decisions based on scientific data
- Ability to use OE tools such as RCAs to solve problems in lab investigations, quality investigations
Environmental Health & Safety (EHS) Responsibilities
- Perform duties in a compliant manner and behave in accordance with site SOP’s
- Read and understand Standard Operation Procedures. Report all accidents, incidents and any EHS issues using the appropriate process/system
- Ensure all engineering changes made have safety considerations
- Ensure Basis of Safety files are available and up to date for processes
- Behave in accordance with our Quality Management System requirements.
- Maintain GMP standards.
- Attend training and complete assessments as required.
- Work in a GMP quality compliant manner at all times.
- Honours degree in chemistry/analytical chemistry
- PhD/Masters in analytical chemistry
- An up to date knowledge of Quality guidelines e.g. ICH, FDA, IMB, QMS and GMP
- Have a sound technical knowledge of their specific discipline
- Detailed knowledge of the cGMP requirements relevant to the role
- Embrace Quality Leading Edge Principles and Behaviours
- Knowledge of the CAPA’s, project planning/management, managing groups, running QIPs.
- Familiar with GMP as applied to an analytical laboratory
- A demonstrated commitment to Quality/QMS, EHS, OE/Continuous improvement and Leading Edge behaviours
- At least 3 years relevant experience
- Experience of interacting with R&D Chemical Development Analytical Sciences
For a confidential discussion and more information on the role, please contact Laura Jevens on 021 4911060 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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