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QC Analytical Laboratory Team Leader

Job LocationPlymouth
EducationNot Mentioned
Salary£30,000 - £32,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Quality Control Analytical Team LeaderMedical Devices Plymouth Permanent Contract Focus of the roleSupervise and effectively utilise the Quality Control Analytical Group resources to ensure timely and effective inspection and testing of raw materials, in progress, finished product, stability program and non-routine analytical requests according to approveddocumentation and Quality Management System requirements including:

  • Tensile Testing
  • Packaging Integrity Testing
  • Material Fluid Handling
  • Moisture Content
  • Atomic Absorption (AA)
  • High Performance Liquid Chromatography (HPLC)
  • Viscosity
  • Titration
  • Elution Testing
  • Flame Photometry
Role Responsibilities
  • To ensure material and product quality conformity across the business.
  • To ensure Quality Management System, Regulatory and Customer requirements
  • for product quality are met.
  • To ensure timely and effective provision of analytical test data and reports to support Production, R&D, Sales and Marketing and Quality Assurance functions
  • Timely and effective inspection and testing of raw materials, work in-progress finished product, stability program and analytical requests.
  • Timely and effective resolution of quality concerns including investigation of Out of Specification (OOS) results.
  • No repeat occurrences of quality concerns with minimal OOS results attributed to analytical error.
  • Accurate and timely reporting of test results.
  • Safe and tidy laboratory environment with up-to-date Risk Assessments.
  • Compliance with Quality Management System, Customer, GMP, GLP and Health & Safety requirements.
Qualification & skills
  • Requires degree level in Chemistry or associated fields, or equivalent industry experience.
  • Experience in testing, developing, and validating analytical test methods in a regulated environment
  • Supervisory / line management experience
  • Understanding of medical devices to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC and ISO 13458 or contract testing to requirements of GLP or ISO 17025
  • Ability to identify material and product defects, which may adversely affect finished product safety, effectiveness, or quality
  • Ability to operate and troubleshoot relevant testing instruments and equipment
  • Ability to statistically analyse test results and generate accurate reports
  • Able to demonstrate achievement and continual improvement against key performance targets and Quality Objectives
  • Ability to identify and implement continual improvement initiatives
  • Knowledge of and experience in root cause analysis and problem-solving techniques
  • Able to manage own time effectively, prioritise tasks, utilise resources effectively and deliver to critical deadlines and
  • Excellent communication skills; written, verbal and presenting
  • Certified Quality Auditor or Lead Auditor
  • Project Management skills
  • Keen attention to detail.
  • Flexible and adaptable to changing work environment.
Salary & Benefits Salary: £30,000 - £32,000 per annumYoull receive a fantastic benefits package including pension scheme, Private Medical, healthcare cover, life assurance, and much more!

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