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: email@example.com
12th January 2015
DEPUTY QUALITY MANAGER FOR MICROBIOLOGICAL LAB
Vacancy in our microbiology laboratory based in Galway. The role is full time and permanent following an initial 6 months probation period.
The complete responsibility for overseeing compliance including the upkeep and maintenance of cGMP, FDA and ISO 17025 reporting to the Quality Manager.
EXPERIENCE / QUALIFICATIONS:
- Minimum of a Level 7 degree in Microbiology or related qualification.
- 5yrs + experience within Pharmaceutical GMP lab environment
- Minimum 2yrs experience within Quality role of Pharmaceutical GMP lab environment
- Highly organised
- 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 own initiative, motivate personnel to achieve high quality and compliance standards
- Ability to critically review analytical data, processing excellent attention to detail is a must
- Experience in method development and validation
- Good attention to detail
- Good working knowledge of Microsoft Office: Excel, Word, PowerPoint
- Highly motivated
- Full driving licence
- Accountable for frontline quality management of the Microbiological Laboratory activities.
- Overall responsibility for the maintenance of cGMP, FDA and ISO17025 quality systems within the Microbiological Department
- Preparing for and facilitating all compliance inspections, customer and quality audits for the Micro Laboratory
- Ensuring that all quality systems within the department are adhered to on a daily basis, GMP and ISO 17025. Initiating actions to prevent the occurrence of quality system errors and non conformances
- Dealing with CAPAs, lab deviations and out of specification investigations for the Microbiological Lab
- Participating in creating, reviewing updating and approving documentation and test records
- Participating in methods development and method validation
- Ensuring the integrity of results delivered to and reported to clients
- Ensuring equipment is compliant to IQ, OQ and PQ requirements and is calibrated/ verified on an annual basis
- Reporting on the performance of the quality systems within the Micro Lab to management.
- Ensuring that trend analysis of proficiency testing, IQC, EM are completed on a regular basis
- Ability to liaise with customers to interpret results and problem solve
Suitable applicants are invited to email their application with CV to firstname.lastname@example.org Please quote ref: MP-MO-0914 in your application email.
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 email@example.com. 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: firstname.lastname@example.org