Collins McNicholas

JOB TITLE:  

QC Bioassay Team Leader

COMPANY:

Global Biologics Company

LOCATION:

Nordics

KEY RESPONSIBILITIES

  • Be able to work in accordance with GMP practices, conducting all activities in a compliant manner.
  • Willing to take on additional activities with little to no supervision
  • Contribute to continuous improvement of procedures and processes at the company.

 

JOB DESCRIPTION 

 

Responsible for the following testing, as and when required:

  • ELISA based assays
  • Ligand binding assays
  • Cell based assays
  • Preparing working cell banks using tissue culture techniques
  • Microscopy work
  • Aseptic practices

 

Responsible for performing the following activities:

  • Communicating business critical Information to the line manager
  • Play a role in the day to day management of the Quality Control department
  • Help establish and maintain departmental metrics
  • Lead Technology Transfers / Validations
  • Review and approve, where required, generated technical documentation
  • Initiating deviations, leading level 2 deviations, and supporting staff involved in level 2 and 3 deviations
  • Raising and leading OOS/OOT investigations
  • Scheduling of daily activities within the department
  • Ensuring completion of daily work activities
  • Perform routine 1: Ts with direct reports
  • Assist with objective setting and tracking
  • Provide oversight and technical guidance to ensure the right level of scientific ability within the department
  • Review of laboratory documentation including testing paperwork
  • Ensure that master laboratory records are completed to the required standards
  • Identifying required document changes and empowering staff to ensure changes are implemented in a timely fashion
  • Identify and lead change control direct or through others
  • Work with fellow Team Leaders within Quality Control on departmental initiatives
  • support facility tours
  • Ensure maintenance of regulatory readiness and active participation in regulatory preparation and inspections
  • Be aware of and comply with the company current EHS policies
  • Participate in training of staff

Additional Skills:

  • Communication Skills: Excellent written and verbal communication skills
  • Linguistic Skills: Fluent command of the English language, both written and verbal
  • Computer Literacy: Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel
  • Organisation and Management Skills: Will be required to participate and make positive

contribution to team meetings. Responsible for individual performance management.

  • GMP Experience: Will be expected to work to and comply with the requirements of the company QMS cGMP and Good documentation practises and policies. Will participate in self inspections and regulatory inspections

 

EDUCATION AND EXPERIENCE

  • Education: Minimum of a MSc in a relevant scientific discipline and direct industry experience or 5 years’ experience in Pharmaceutical or Biopharmaceutical sector.
  • Experience: Knowledge and proven experience of working to GMP standards. Two years people management experience

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