Manages, implements and coordinates quality assurance program to prevent or minimize risk to the integrity of data at the Decatur site. The QA Manager of Data Integrity and compliance provides independent oversight to the data integrity program for the facility including data generation and review. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with Akorn policies and procedures as well as cGMPs and industry data integrity expectations. The QA Manager of Data Integrity & Compliance will assist in hosting audits and tracking audit responses to ensure they are timely and complete. The QA Manager of Data Integrity & Compliance reports directly to the Director of Quality Assurance.
- Develop and maintain Data Integrity System for the site, including ownership of Data Integrity SOPs, development
- Audits data from Quality Control Laboratories (Chemistry and Microbiology)
- Oversees the investigation of discrepancies in Quality Control Laboratories
- Performs reviews of site NDA/ANDA filings
- Provides oversight to the Commercial and ANDA stability programs.
- Provides oversight and administration of GMP-IT Systems (Computerized data systems)
- Review/close out any aborted or rejected batch records.
- Review/close out any non-commercial (ANDA Exhibit, Engineering etc) batch records.
- Review/close out all media fill batch records.
- Provides data from batch record review and stability reports for analysis during annual product reviews.
- Review method validation/verification and transfer protocols and final summary reports/data.
- Review process validation/verification protocols and final summary reports/data.
- Review validation qualification and requalification protocols and final summary reports/data.
- Performs pre and post review/approval of change controls and associated action plans/validation activities.
- Assist in hosting, Internal, Customer and Regulatory Agency.
- Conduct routine Data Integrity related training.
- Provides and tracks responses to audit observations and deficiencies..
Responsible for the overall direction, coordination and evaluation of this unit, and the compliance and integrity of data at the Somerset site.
- Responsible for performance reviews, goal setting and personnel development plans for Quality Assurance Data Reviewers, and Quality Control Investigators
- Providing regular performance feedback (praise and developmental) to members of QA team
- Assists in recruiting, interviewing and hiring qualified employees to fill open positions.
- Planning, assigning and directing work
- Addressing complaints and resolving personnel problems within the department
- Maintaining confidentiality of information.
Bachelor's Degree (BS or BA) in a science related filed (i.e. math, chemistry, biology) required
Minimum 5 years demonstrated excellence in a managerial or supervisor role in the pharmaceutical industry
Experience in a laboratory setting is preferred
Experience in validation (method or process) is preferred
Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopea, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's.
Ability to write, read and apply technical scientific writing, procedures and quality policies
Ability to work independently in an efficient and detail-oriented manner.
Ability to work on multiple projects and priorities in a concurrent manner.
Ability to work in an independent manner, as well as a group environment
Ability to apply deductive reasoning and analytical thought to understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with a high level of office stress.
Ability to maintain confidentiality of work assignments and personnel issues