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QA Operations Specialist

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QA Operations Specialist
We are recruiting, on a consulting mandate, an experienced QA operations Specialist, for a long term contract.

Responsibilities:
  • Perform batch record review and prepare batch release documentation.
  • Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility.
  • Reviews and approves as QA representative qualification and validation activities documents (protocols and reports).
  • Represents QA within department and cross-functional project teams according to assignments.
  • Acts as backup for colleagues within QA Operations team.
Profile:
  • At least 3 years of experience in a pharmaceutical company or other related industry.
  • BS or MSc in Science or related field.
  • Good understanding of cGMPs and FDA regulatory requirements.
  • Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
  • Proven interpersonal, collaborative and organizational skills.
  • Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
  • Ability to focus attention to details.
  • Good written & oral communication skills.
  • Investigational and problem-solving skills.
  • Knowledge of most common office software (Microsoft Office).
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