Supervisor, Manufacturing Batch Record Review
Welcome to Catalent, a leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. We are seeking a highly motivated and experienced Supervisor, Manufacturing Batch Record Review to join our team. In this role, you will oversee the review and approval of batch records to ensure compliance with cGMP guidelines and company procedures. The ideal candidate will have a strong background in pharmaceutical manufacturing, exceptional attention to detail, and excellent leadership skills. If you are passionate about ensuring quality and efficiency in the manufacturing process, we encourage you to apply for this exciting opportunity.
- Oversee the review and approval of batch records for pharmaceutical manufacturing.
- Ensure compliance with cGMP guidelines and company procedures.
- Train and supervise team members in batch record review processes.
- Identify and communicate any discrepancies or issues with batch records.
- Collaborate with cross-functional teams to resolve any quality or compliance issues.
- Monitor and maintain batch record review timelines to meet production schedules.
- Continuously evaluate and improve batch record review processes for efficiency and effectiveness.
- Provide guidance and support to team members on complex batch record review issues.
- Stay up-to-date with industry regulations and cGMP guidelines related to batch record review.
- Participate in internal and external audits and inspections related to batch record review.
- Lead investigations into batch record errors or deviations and implement corrective actions.
- Foster a culture of quality and compliance within the manufacturing department.
- Communicate any changes or updates to batch record review procedures to team members.
- Collaborate with other departments to ensure timely release of batches for further processing.
- Communicate and report any potential risks or issues related to batch record review to management.
Strong Knowledge Of Cgmp Regulations And Industry Standards: A Supervisor, Manufacturing Batch Record Review At Catalent Must Possess A Thorough Understanding Of Current Good Manufacturing Practices (Cgmp) Regulations And Industry Standards, Including Fda And Ich Guidelines.
Experience In Pharmaceutical Manufacturing: Candidates Should Have A Minimum Of 3-5 Years Of Experience In A Pharmaceutical Manufacturing Environment, Preferably In A Batch Record Review Role. This Experience Should Include Knowledge Of Manufacturing Processes, Equipment, And Documentation Practices.
Attention To Detail And Strong Analytical Skills: The Role Of A Supervisor, Manufacturing Batch Record Review Requires A High Level Of Attention To Detail And The Ability To Analyze Complex Data. Candidates Should Have A Strong Track Record Of Accuracy And A Keen Eye For Identifying Discrepancies And Errors.
Excellent Communication And Leadership Skills: As A Supervisor, This Role Will Require Overseeing A Team Of Batch Record Reviewers. Strong Communication And Leadership Skills Are Essential In Order To Effectively Train, Motivate, And Manage Staff, As Well As Communicate With Other Departments And Management.
Bachelor’s Degree In A Related Field: A Bachelor’s Degree In A Relevant Field Such As Pharmaceutical Sciences, Chemistry, Or Engineering Is Preferred For This Role. A Combination Of Education And Relevant Experience May Also Be Considered.
Process Improvement
Communication
Time Management
Attention to detail
Leadership
Analytical Thinking
Quality Control
Team Building
Organization
Problem-Solving
Adaptability
Decision-Making
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Supervisor, Manufacturing Batch Record Review in Harmans, Severn, MD, USA is $65,000-$80,000 per year. Salaries may vary depending on the specific industry, company, and individual's experience and qualifications.
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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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