Batch Record Reviewer Documentation Specialist
Batch Record Reviewer Documentation Specialist
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
The Batch Record Reviewer - Documentation Specialist will provide direct support to the Production team for documentation and training activities. This role is essential in ensuring the accuracy and compliance of Batch Manufacturing Records (BMR) and other production documentation. The specialist will also support and deliver training for the production team on documentation completion.
Responsibilities
- Supporting the review of batch manufacturing records including trending of errors and feedback to production operators to ensure continuous improvement.
- Ensuring the timely closure of batch manufacturing steps in SAP
- Provide support on documentation required for production
- Draft of the manufacturing documentation (Master Batch Record) in collaboration with the Technology Transfer and the Cleaning & Process Validation group
- Authoring and reviewing production documentation such as Standard Operating Procedures (SOPs) Training Forms Risk Assessments and Audit Trail Reviews using the Electronic Documentation Management System.
- Coordinating investigations in error to generate preventative actions
- Own change control related to BMR and documentation.
- AttendTier 1 huddles to update teams on relevant Batch Record position
- Track Progress of Batch Record review
- Using Practical Process Improvement to drive improvement initiative of our Batch Record and other documentations.
Minimum Requirements/Qualifications:
To thrive in this role you should possess the following qualifications and experience:
- Proven working knowledge of the principles and guidelines for Good Manufacturing Practice (GMP) related to production activities documentation and data integrity requirements.
- A minimum of 5 years experience in pharmaceutical manufacturing with a preference for specific experience in sterile filtration products.
- Strong proficiency in Microsoft Office applications and a high level of general computer literacy.
- Demonstrated experience in effectively collaborating with collaborators including colleagues senior management and customers.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
