Summary The Batch Record Reviewer ensures GMP compliance and adherence to SOPs through the review and approval of Batch Records, drug products and components.
Essential Duties and Responsibilities - Review and approve pre-execution and post-execution batch records to ensure cGMP compliance and adherence to SOPs
- Review and approve components and bulk drug product to ensure proper quality and compliance standards are met.
- Approve labels for release to production, ensuring proper quality and compliance standards are met, as required.
- Provide timely communication of quality issues to management as needed.
- Participate in investigations, deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes.
- Assist in training employees in cGMPs, SOPs, or quality issues as necessary
- Review and approve Distribution Instructions
- Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP standards, FDA and all competent authority regulations and requirements
- Review technical problems, procedures, complaints and non-conformance of departments, materials and processes.
- Prepare written reports of investigations with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.
- Review and approve Analytical Reports/COA's to ensure proper quality and compliance standards are met.
- Maintain accurate, detailed records of work performed
- Provide timely communication of quality or cGMP issues to supervisor
- Participate in investigations, deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes.
- Work with internal staff to meet scheduled requirements in a timely manner.
- Ensure that employees and visitors comply with applicable Sharp Clinical Services SOP's.
- Is accountable for maintaining a clean, orderly and safe work environment
- Provide support for and leadership for QC Inspectors.
- Adhere to set safety standards.
- Participate actively in regular meetings.
- Achieve expected performance measures.
- Other duties as assigned.
QualificationsTo 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.
- High School Diploma, Bachelors' Degree or equivalent in related field preferred.
- Prior experience in pharmaceutical or biotech manufacturing in a Quality or Compliance role preferred.
- Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
- Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
- Ability to interpret and implement cGMPs, FDA & DEA Regulations and CFRs.
- Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Access.