Validation AnalystVacancy posted: Monday, 10 October 2016
Closing date: 07 November 2016
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. We have an exciting opportunity for a Validation Analyst to join our QA team in Glasgow.
The post holder will be the principal owner of the AMRI (Glasgow) Validation Master Plan in conjunction with Production, Engineering, Microbiology, Quality Control and Quality Assurance team, and will be responsible for ensuring that all equipment for GMP use within the Glasgow site is validated.
Quality Assurance operates as a support function for site, ensuring that all activities adhere to the requirements of the Quality Management System and that the site operates in compliance with current GMP. All work is performed within the Glasgow facility and operates to ensure that sterile products are manufactured to GMP in a consistent manner.
Reporting to the Quality Assurance Manager, your role will be wide ranging and you will be responsible for the tasks as below:
- Management of validation master plan and review of requirements for ongoing validation with Quality Assurance to ensure that planned Glasgow production, microbiology and QC activities are suitably supported and underwritten by existing validation data
- Responsible for provision, compilation and delivery of validation protocols and review of sub-contractor protocols and reports.
- Performs technical review of equipment records for completeness, compliance with internal procedures and GMP prior to review by QA Manager, Head of Quality or nominated deputy.
- Works with Production and QA to ensure the correct and timely validation of any new equipment in accordance with GMP and site goals/timelines.
- Trends and tracks validation, maintenance and performance status of all equipment
- Ensure that equipment breakdown/repair is managed by departments and escalate any significant breakdown/repair to QA Manager and Engineering
- Compile deviations, CAPA and change controls for equipment validation
- Lead and support training of staff in equipment control procedures
- Conduct Gap analysis and observations of current equipment usage and maintenance to ensure consistency and adherence to documented current best practice
- Work with Process Improvement and all other departments to ensure that training in new processes is conducted and effective for all relevant personnel
- Maintains Equipment control folders and archiving
- Assists in writing and revising validation SOPs.
- Assists in the co-ordination of equipment related change controls.
Support of Quality and AMRI Glasgow site
- Ensure that any deviations and investigations are carried out in a timely fashion and that any corrective actions are communicated.
- Participate in maintaining audit readiness of facility
- Contribute to continuous improvement activities related to equipment validation, maintenance and performance status
- Participation in client and regulatory audits as required
- Participation in self inspections
- Provide support for batch manufacturing record review
- Educated to Degree level or equivalent in a related science or engineering field
- Previous experience in a similar role
- Understanding of regulatory commitment including GMP, ICH and COSHH
- Planning & organisational skills
- Good communication skills
- Quality focussed
- Focussed on delivery
- Understanding project planning dynamics and interactions
Benefits package includes: Contributory pension scheme (employer up to 9%), Private Health cover after 6 months, dental and health cover voluntary schemes, childcare voucher scheme, annual gym contribution, 25 days holiday (rising to 30) plus 9 bank holidays.
If you have the relevant skills and expertise we would love to hear from you and look forward to receiving your application. Please also provide a covering letter outlining your availability and salary expectations.
AMRI provides equal employment opportunities to all individuals without regard to race, colour, religion, sex, national origin, age, disability, marital status, veteran stats, sexual orientation, citizenship, or any other characteristics protected by law. To ensure that employment decisions are consistent with equal employment opportunities, AMRI imposes only job-related requirements for these opportunities.
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