drjobs Documentation officer

Documentation officer

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1 Vacancy
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Job Location drjobs

Monza - Italy

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Work Schedule

7 1/2 hr shift

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Job Responsibilities

  • Coordinate the batch record review process to ensure strict compliance with regulatory and company standards.
  • Collaborate with crossfunctional teams to identify and implement standard methodologies for batch records.
  • Conduct detailed reviews and audits of batch records to identify and resolve any discrepancies.
  • Train and mentor team members to ensure detailed of batch record reviews.
  • Develop and maintain Standard Operating Procedures (SOPs) related to batch record review.
  • Ensure timely and accurate documentation of all batch record activities.
  • Assist in the preparation for and participation in regulatory inspections and audits.
  • Lead initiatives to continuously improve the efficiency and effectiveness of the batch record review process.

Job Requirements

  • Strong understanding of regulatory requirements and compliance standards.
  • Excellent attention to detail and ability to conduct thorough audits.
  • Outstanding communication and collaboration skills.
  • Ability to train and mentor team members effectively.
  • Ambitious and proactive in identifying and implementing process improvements.

Required Experience:

Unclear Seniority

Employment Type

Full-Time

Company Industry

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