What are the responsibilities and job description for the Batch Record Reviewer position at Sharp Clinical Services?
SUMMARY
Responsibilities include review of line documentation related to contract packaging. Will follow up on customer inquiries as they relate to same documentation and compliance issue. Responsible for participating in internal, external and regulatory audits at the discretion of senior management. Position is final review and ultimate release for product distribution.
The impact of review process could expose the company to criticism from customers.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of responsibilities related to record review. Other duties may also be assigned.
Responsible for review of documentation related to primary packaging after completion of reconciliation.
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.
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 reviewing and approving the QAD Item Master Maintenance and Route Maintenance.
SUPERVISORY RESPONSIBILITIES: None
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duties and responsibilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
High School Degree is required. One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.
- General knowledge of FDA regulations related to cGMPs.
- General 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.
MATHEMATICAL SKILLS:
Ability to apply mathematical operations to such tasks as they apply to the pharmaceutical industry. This includes an understanding of statistical sampling plans.
LANGUAGE SKILLS:
Ability to respond to common inquiries or complaints from customers. Ability to respond to inquiries from peers and superiors. Ability to effectively present information to the following groups:
- Internal: Frequent contact with Quality Department, Project Managers, New Business Development, Material Management and Operations Department employees for information on quality documentation issues and cGMP issues.
- External: Occasional contact with customer representatives related to documentation.
REASONING ABILITY:
Ongoing contact with internal Sharp Operations, Project Managers, New Business Development, Material Management and Quality Department employees. Frequent contact with customer representatives concerning documentation issues, as well as cGMP’s. A thorough understanding or each aspect of the job is required. Good organizational skills are necessary. Good reasoning skills for analysis and problem solving are needed.
COMPUTER SKILLS:
Must be proficient in Microsoft Office Suite, QAD and Veeva
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 accommodations 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 accommodations 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.
