Our Current Listing on irishjobs.ie
SENIOR ANALYTICAL CHEMIST
Reporting to: Quality Manager
EXPERIENCE / QUALIFICATIONS
- Must have a minimum of Three years industrial experience in a GMP regulated QC chemistry laboratory.
- A degree in Analytical Chemistry, Pharmaceutical Chemistry or other related qualification is required.
DUTIES & RESPONSIBILITIES
- Ensuring that all operations within the chemistry laboratory are performed in accordance with applicable regulations, standards and guidelines.
- Selection, installation, qualification and ongoing maintenance of laboratory equipment in accordance with the CLS laboratory quality system and GMP.
- Generation of documentation to support test method transfers from clients.
- Execution of testing as per approved protocols and test method etc.
- Write up of all test results as per GMP and in accordance with the Quality System including Out of Specification results and Laboratory Deviations.
- Review and approval of Laboratory quality records as per GMP and in accordance with the Quality System e.g. Out of specification results, laboratory deviations etc.
- Training of junior staff.
- Participation in self inspections audits.
- Communicate with customers in relation to technical queries, forecasting etc.
- GMP review of Laboratory log books.
- Participate in Laboratory audits e.g. Regulatory Customer.
- Interpret analytical results and resolve technical and/or operational problems and provide technical advice and support to all technicians/analysts.
- Prepare, review and revise, as required, SOPs and specifications. Initiate and review out of specification and deviation reports, protocols and other appropriate documentation for proper functioning of the lab operation.
- Support and manage projects to be on time, within budget and to meet business requirements.
- Ensure the validation status for all test methods and laboratory equipment is compliant with regulatory requirements and internal procedures.
Please email your application letter and C.V. to Miriam Murphy: firstname.lastname@example.org
EXPERIENCED MICROBIOLOGY QC ANALYST
Position maintaining regulatory compliance through, sample processing, laboratory testing, maintenance, training, SOP’s, validation and cleaning within the laboratory.
- Perform analysis on Raw Material, Intermediate, Stability samples and/or Finished Products.
- Laboratory support testing including consumable control and qualification.
- Validation and qualification of test methods
- Responsible for calibration and use of laboratory instrumentation.
- Perform and assist in additional duties as directed by the Supervisor.
- Complete documentation associated with test results in a timely manner.
- Report and document any non-conformances to the Supervisor.
- Preparation and review of area documentation (e.g. SOP’s, Reports, Protocols).
- Assist in the training of other analysts.
- Ensure training compliance within the assigned work area and QC.
- Adhere to safety systems within the laboratory and on site.
- 3rd level qualification in Microbiology
- A minimum of 3 years’ experience in a GMP Lab, (Bioburden, endotoxin)
- Strong analytical and problem solving ability.
- Ability to prioritise, demonstrating good time management skills.
Contact: Anne O’Donnell
STERILITY ANALYST LEAD
ROLE AND RESPONSIBILITIES
- The main aim of the role is to carry out sterility testing and to master the range of techniques appropriate for the work area. Become familiar with work practices and documentation requirements.
- Preparing and conducting validation and performance qualification of new products.
- Preparing and executing annual re-qualification protocols and sterility test validation protocols. Responsible for SOP generation and overseeing of all routine sterility testing in the Isolator
- Responsible for all deviation investigation, root cause analysis and Laboratory investigations for the Microbiology department
- Reporting client test results and acting to ensure all clients requirements are met.
- Gain an insight into the processes / procedures of the company’s business including customer awareness, lab safety and efficiency.
- Training additional analysts to support this area
- Act on own initiative and to learn as quickly as possible any tests that they are required to do.
- Responsible for gaining proficiency in a certain number of tests/area of testing.
- Perform techniques / tests that they are qualified to do in terms of completed training records and as directed by the laboratory senior.
- Ensure that all documentation and calculations are carried out on time, accurately and legibly
- Keep training records up to date and to initiate training as per training plan where possible when free from work
- Adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.
- Ensure that customers’ requirements are fully met and in so doing be flexible to work in any area of the business as is required.
- Identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement.
- A Degree or Diploma in Microbiology or a related discipline is desirable
- 2+ years GMP experience
- Background in Sterility
- Good team player, organised, accurate, have strong documentation skills
- Passionate about quality and customer service.
- Good communication skills both internally and externally.
- A good role model for junior
Contact: Anne O’Donnell E. email@example.com
MICRO LABORATORY SUPERVISOR
ROLES AND RESPONSIBILITIES
- Frontline management in the day to day management of all laboratory activities.
- Allocation, scheduling and managing lab resources.
- Performance management of direct reports, including development plans for all analysts.
- Ensuring that all quality systems within the department are adhered to on a daily basis, GMP and ISO 17025.
- Ensuring results and reports are delivered on time to clients. Liaising with customers on all matters involving support.
- Reviewing analyst’s documentation, data, and lab investigations reports, deviations, customer complaints etc.
- Ensuring that staff training, equipment qualification/calibration and method validation is adequate and up to date.
- Preparing the lab for internal and external audits, maintaining compliance to good housekeeping and safety standards.
- Monthly reporting of trends and KPI management (training available).
- Motivate staff to achieve targets and optimise the use of resources at all times.
- 3rd level degree in microbiology
- 5yrs + experience within a GMP lab environment.
- Minimum 2yrs supervisory experience within pharmaceutical GMP lab environment.
- Have a professional, pro-active approach to work combined with strong leadership skills and an ability to work efficiently under pressure.
- Must have good written and verbal communication skills.
- Be capable of working on your own initiative motivate your team.
- Ability to critically review analytical data, excellent attention to detail is a must.
- Experience in method development and validation.
Contact: Anne O’Donnell
EXPERIENCED PHARMACEUTICAL CHEMIST
EXPERIENCE / QUALIFICATIONS:
- Must have a minimum of Two to Three years industrial experience in a GMP regulated QC chemistry laboratory.
- A degree in analytical chemistry, pharmaceutical chemistry or other related qualification is required.
- Must have 2+ years experience on HPLC and familiar & fluent with Empower software.
- Strong documentation skills are required.
- Must have strong time management skills.
- Must possess key competencies: Team Work, Flexibility, Planning/Organisation, Problem Solving, and Communication.
- Experience with regulatory inspections and interacting with inspectors.
- Strong organizational skills, including ability to follow assignments through to completion.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral) skills.
- Strong skill in working independently and to effectively interact with various levels.
- A strong team player is essential.
- Must be motivated, focused and technically strong.
A good remuneration package is available for the suitable candidate.
Suitable applicants are invited to email their application with CV to firstname.lastname@example.org. Please quote EPC100114 in your application email.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Must have a minimum of three years industrial experience in a 17025 accredited laboratory.
- A degree in analytical chemistry, organic chemistry or other related qualification is required.
- A strong track record in the validation of chromatography techniques
- Have technical knowledge in the development and validation of analytical methods as per ICH guidelines
- Possess the ability to troubleshoot instrumentation/methodology/data validation issues systematically and utilise strong technical knowledge in resolving issues
- Must be motivated, focused and technically strong
Reporting to: Quality Manager
Salary: A good remuneration package is available for the suitable candidate.
Please send applications with cover letter to: email@example.com