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Quality Control Manager

Tuesday, may 05, 2020
Description

Why work for this company?

Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.

Company Profile

  • 65+ years of experience in animal health
  • Nearly $6 billion annual revenues
  • 25 manufacturing sites around the world
  • 10,000 employees worldwide of which 1,100 employees are committed to R&D

Role Purpose

This role within the Quality Control group is primarily responsible for the coordination of in-process and final product testing & release of recombinant antibodies for veterinary use. The position also involves taking a lead in the development, transfer and validation of new bioanalytical methods to support the overall product development programme. The role is responsible for the initiation, coordination and management of stability studies from development through to commercialisation. The role will involve interacting with cross functional teams and external contract testing service providers.

Reporting Structure

The position will report to the Site Head of Quality.

Duties & Responsibilities

  • Build, lead and develop a team with expertise in development, validation & transfer of analytical test methods used for the testing and characterisation of biopharmaceuticals and associated raw materials
  • Develop, optimise and validate all required analytical test methods, either in-house or in collaboration with external service providers
  • Manage technical transfer of analytical test methods from external partners to the Tullamore facility
  • Coordinate in-process and final product testing & certification of recombinant antibodies for veterinary use in an efficient & timely manner
  • Oversee the initiation, coordination and management of stability studies from development through to commercialisation
  • Establish test method and validation protocols, SOPs, specifications and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, setting specifications, monitoring Out of Specifications and taking a lead role in laboratory investigations
  • Liaise with the manufacturing team to support and provide in-process & release testing of the ongoing manufacturing campaigns within required timeframes
  • Work closely with manufacturing/process development to support the development of a robust manufacturing process and transfer to the GMP facility as required
  • Assume an active role in audit preparation ensuring the QC function is audit ready
  • Work closely with specialist contract testing service providers to ensure execution of all deliverables
  • Oversee microbiological & environmental monitoring testing programs to support GMP manufacture
  • Oversee outsourced raw material testing requirements to support GMP manufacture
  • Support equipment qualification projects and work with vendors to ensure execution of all deliverables, including equipment qualification and validation activities
  • Provide technical reports on completion of development and validation tasks
  • Develop good project management & planning skills to enable coordination and management of various project activities
  • Participate in Internal Quality Audits
  • Participate in Quality and Safety regulatory audits.

POSITION SPECIFICATION

Qualifications, Experience, Skills, Knowledge and Attributes

  • PhD, MSC in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience.
  • At least 5 years' relevant experience in development / validation of bioanalytical test methods
  • Proven ability to manage or supervise work in a laboratory
  • Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, HPLC, Capillary Electrophoresis, MS, Glycan analysis, potency methods
  • Qualification / Validation of test methods
  • Good knowledge of regulatory guidelines relating to analytical development and validation
  • Good knowledge of release testing, specification setting and stability study requirements
  • Ability to write relevant sections of CTD for regulatory submission
  • Analytical methods required for process characterisation and validation
  • Knowledge of Equipment Qualification requirements with experience dealing with suppliers of analytical equipment and materials
  • Management of CMO / CRO activities.

Due to the high volume of applications we get, please be advised that if you do not get a response within 7 working days your application has not been successful.

Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003


Job Reference:QCM
Position Type:Permanent
Sector:Biotechnology & Pharmaceutical, pharmaceutical
Working Hours:Full-Time
Location:Offaly, Offaly, Ireland
Salary:Dependent on Experience
Contact:Randstad Financial & Professional, Randstad Financial Services, London, United Kingdom
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