GlaxoSmithKline

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OQ Specialist (Biotech)



Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art biopharmaceutical manufacturing environment?  If so, this OQ Specialist role could be an ideal opportunity for you.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Perform rapid response, walk throughs, process assessments, and change over walk-throughs
  • Review executed solution batch records and executed BDS process batch records
  • Review master batch records
  • Review autoclave records and equipment alarms
  • Review FAC alarms and cleaning verification forms
  • Status label BDS
  • File QA documents and enter data in databases
  • Review EMW data for facility and EM for bulk fills
  • Review change over data
  • Review supporting batch record documentation, as needed
  • Attend cross functional meetings as OQ representative
  • Perform self inspections and assist in internal audits and regulatory audits
  • Review deviations and CAPAs
  • Lead training sessions
  • Performs other functions as necessary or as assigned.
  • Can perform the MERP coordinator role.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelors Degree in Science or Engineering

  • 2-5 years in a GMP environment - or equivalent of education and experience

  • PC literate

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Work well in cross-functional teams
  • Ability to multi-task and work under pressure

  • Good communication and interpersonal skills

  • Good organization skills

  • Attention to detail

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

*LI-GSK

GSKBiopharm_manufacturing

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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