QC Analytical Project Manager

We are currently looking for a QC Analytical Project Manager to join a global pharmaceutical company based in the Durham area.

As the QC Analytical Project Manager you will be responsible for supporting manufacturing processes for customers biologic drugs and offering stability studies to support customer drug substance and drug products.

We will be looking for candidates with some or all of the following skills / competencies: project management, quality control, analytical, cGMP, GMP, pharmaceutical, biopharmaceutical, biology, chemistry, biologics.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QC Analytical Project Manager will be varied however the key duties and responsibilities are as follows:

1.

Represent all of QC at the program level.

Responsible for all QC activities relating to the programme ensuring they are completed in the required timelines and in accordance with cGMP quality systems.

2.

Own S&OP business milestones for projects, provide timely identification and escalation of at risk milestones using business tools (eg: Gantt charts, trackers, risk assessments, etc) and drive remediation or mitigation.

3.

Drive the programme within QC from kick off through to disposition (including critical GMP prep activities such as Method qualification and Cleanability/Swab recovery studies).

4.

Continuously driving the improvement of departmental processes and procedures related to the Analytical Project Manager role.

5.

Ensure all activities are in accordance with cGMP quality systems and ensure QC is continually inspection ready.

6.

Represent the department for owned projects at audit, inspections etc.

Lead or aid complex investigations and manage the reporting of out-of-specification results and deviations, ensuring that the correct pace is set and using appropriate tools (eg: fishbone, RCA, etc) to ultimately deliver meaningful CAPA.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QC Analytical Project Manager we are looking to identify the following on your profile and past history:

1.

Relevant degree in a Biology or Chemistry related discipline, with a good understanding of analytical techniques specific to pharmaceutical or biopharmaceutical analysis.



2.

You will have experience of cGMP analytical activities, plus evidence of delivering projects on time and on budget.



3.

Self-organisation, self-motivation and the ability to prioritise.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development.

We welcome applications for any applicant who fulfil the role requirements for this position.

HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists.

We look forward to helping you with your next career moves.


  • Start: 13/06/2018
  • Rate: Dependent on experience
  • Location: County Durham,England
  • Type: Permanent
  • Industry: Pharmaceutical
  • Recruiter: Hyper Recruitment Solutions
  • Contact: Eve Hegarty
  • Tel: 0203 910 2980
  • Fax: 0203 225 5120
  • Email: to view click here
  • Reference: J56263
  • Posted: 2018-06-13 17:26:16 -

  • View all Jobs from Hyper Recruitment Solutions


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