Analytical Lab Manager
Job ID: JOB-12799
Analytical Lab Manager
Ready to join one of the truly great companies in Ireland? We have a really exciting job opportunity for a Analytical Lab Manager.
Join a super team of people and a company that offers exceptional salaries and benefits packages. Let’s have a conversation to find out more about what’s important to you.
The primary function of this role is to manage and coordinate all activities involved in the running of an efficient and effective Analytical Chemistry laboratory. This role reports into the Senior Quality Systems & Analytical Lab Manager.
- Manage all aspects of the Laboratory from the evaluation of the finished product and raw material analysis prior to shipment/use to the completion and approval of associated documentation.
- Maintain acceptable work standards (e.g. safety, environmental, cGMP, housekeeping etc.) agreeing targets and objectives and evaluation of achievement of these objectives.
- To provide technical and problem solving support to the team as required.
- Carry out project work, including the implementation of new specifications and methods of analysis required to comply with pharmacopeia or customer requirements.
- Support Stability Programmes and other engineering and validation studies as required.
- Work with relevant departments to manage new product introductions.
- Manage the maintenance and calibration of analytical equipment and approval of documentation for same. Also ensure laboratory CFR21 Part 11 adherence and qualification of new equipment.
- Approval of Laboratory Investigations and CAPA’s in a timely manner.
- Ensure compliance to current laboratory quality system accreditation and to manage audits as they arise.
- In-depth knowledge of microbiology and sterilisation programmes.
- Management of Microbiology programme, including Bioburden, Endotoxin and Environmental monitoring including air, surface and particulates analysis.
- Management and oversight on the release of product post sterilization
- Responsible for ensuring that appropriate microbiology requirements for registration of products in various markets is completed.
- Responsible for ensuring that product assessments against microbiology requirements in relevant standards are completed.
- To identify any necessary training for the team and to ensure that this training is completed and documented as per Company procedures.
- Carry out regular laboratory team performance reviews to ensure continued focus on optimum performance to meet business and customer requirements.
- Ensure all laboratory and microbiological documentation is kept up to date.
- Supervisory responsibility for those reporting directly to the position.
- Delegates are the analytical laboratory supervisors for analytical activities and Senior Microbiologist for microbiology related activities.
- Delegate for the Director of Quality Assurance.
- Delegate for Person Responsible for Regulatory Compliance (PRRC) as per Regulation (EU) 2017/745.
- Ensure that conformity of the devices is checked in accordance to the Quality Management System under which the devices are manufactured before a device is released.
- Provide monthly/weekly reports and Quality Metrics in a timely manner.
- Work closely with relevant departments globally on the creation and validation of new test methods.
- Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820.
Qualifications / Requirements:
- BSc / Masters with relevant and/or experience of the Drug Combination requirements.
- Excellent organisational skills and motivational skills are required for this role.
- Knowledge of UV Viz, Dissolution and HPLC Equipment and techniques a prerequisite.
- In depth knowledge of FDA, PMDA, TGA and EU regulatory requirements as they apply to the functioning of an Analytical Chemistry laboratory.
- In depth knowledge of Agilent HPLC’s and Empower Software required.
- Excellent technical knowledge in the area of analytical Chemistry.
- Proven People management, problem solving and leadership skills.
- A minimum of 5 years experience from an analytical perspective and a minimum of 3 years in a Laboratory Management role.
For further information on this role please contact Elaine Ferguson on Connect@hero.ie or 087-4108620 Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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