At Catalent, we are looking for a motivated and experienced Batch Record Reviewer to join our team. As a Batch Record Reviewer, you will be responsible for reviewing and approving batch production and control records for compliance with cGMPs and other regulatory requirements.We are looking for an individual with a strong attention to detail, excellent communication skills, and the ability to work well in a team environment. The successful candidate will have experience in the pharmaceutical industry, including cGMPs and experience in batch record review. A Bachelor’s degree in a related field is preferred.This is an excellent opportunity to join a global leader in the pharmaceutical industry and to work with a talented and passionate team. We offer a comprehensive benefits package and competitive salary.
Responsibilities:
- Review and approve batch production and control records for compliance with cGMPs and other regulatory requirements.
- Follow all company policies and procedures related to batch record review.
- Maintain accurate and organized documentation of batch record review.
- Maintain a thorough understanding of cGMPs and industry regulations related to batch record review.
- Communicate effectively with team members to ensure a smooth and efficient review process.
- Provide guidance and direction to team members when necessary.
- Utilize problem-solving skills to address any issues that arise.
- Identify areas for improvement and provide recommendations for process optimization.
- Work cooperatively with other departments to ensure compliance with regulations and company policies.
- Keep up-to-date with industry trends and developments.
Ability To Work In A Fast-Paced Environment
Good Knowledge Of Gmp
Good Knowledge Of Computer Systems
Good Analytical Skills
Good Understanding Of Batch Records
Ability To Identify Discrepancies In Records
Ability To Work Independently And Within A Team
High Degree Of Accuracy And Attention To Detail
Documentation
Quality Assurance
Data Entry
Communication
Attention to detail
Problem Solving
Auditing
Analytical Thinking
Technical Writing
Risk assessment
Process optimization
Regulatory compliance
Process Control
Recordkeeping
Batch Tracking
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
collaboration
Adaptability
Problem-Solving
Decision-making
According to JobzMall, the average salary range for a Batch Record Reviewer in Baltimore, MD, USA is $38,914 - $67,146 per year. The salary range is dependent upon experience, job responsibility, and other factors.
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Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.

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