What are the responsibilities and job description for the Batch Record Review Supervisor position at Sharp Clinical Services?
SUMMARY:
Supervise the batch record review group. Responsible for oversight of the batch record review process to ensure it satisfies GMP and GDP requirements. Responsible for supporting the company with timely and accurate release of documentation to meet customers’ requirements. Responsible for supervising the batch record reviewers and ensuring they meet their responsibilities. This includes a review of line documentation related to contract packaging. Will follow-up on customer inquiries as they relate to same documentation and compliance issues. Responsible for participating in internal, external and regulatory audits at the discretion of senior management. Position is responsible for final documentation review and ultimate release for product distribution.
The impact of the review process could expose the company to criticism from customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Supervisor Batch Record Review position. Other duties may also be assigned.
Responsible for assigning work to the batch record reviewers.
Responsible for prioritizing workloads of the batch record reviewers.
Responsible for ensuring all appropriate documentation is issued to the production floor according to schedule requirements.
Responsible for ensuring group performance metrics are submitted to management as required.
Responsible for reviewing documentation related to primary packaging after completion of reconciliation.
Responsible for critical review of all above documentation for errors, omissions, over-writes and compliance to cGMPs, customer specifications, and internal SOP’s.
Responsible for follow-up on all customer inquiries specific to documentation related to the packaging, testing and release of the work in-process or finished product.
Responsible for final release of work in-process or finished product.
Responsible for participating in internal, customer, and regulatory audits at the discretion of senior management.
Responsible for training of designated peers as a replacement. This is completed at management’s request.
Responsible for review of documentation related to secondary packaging after completion of reconciliation.
Responsible for review of documentation related to clinical packaging after completion of reconciliation.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Direct reports if any and the level of supervision.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
High School Degree is required. Four (4) to six (6) years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.
- Good knowledge of FDA regulations related to cGMPs.
- Good knowledge of quality control/assurance.
- General knowledge of DEA regulations.
- General knowledge of EMEA.
- Excellent detail skills as they apply to documentation review and compliance.
- Good written and oral communication skills.
- Good organizational and planning skills.
- Excellent interpersonal skills.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands, speak and listen. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the production floor. The working environment is clean and not normally subject to hazardous environment or conditions.
Travel to customers on an as needed basis.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
