POSITION SUMMARY:With limited direction from the QA Management, the Manager QA independently manages the QA Documentation group at Forest Cincinnati and manages all QA packaging activities at the Forest Earth City plant.
PRIMARY JOB RESPONSIBILITIES:Coordinate and supervise the activities of the QA Documentation Auditors in Cincinnati and Earth City. Establish work schedules and prioritize activities to meet Forest requirements. Monitor adherence to work schedules. Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems. Assists in the development of budgets for both sites, Schedules work. Responsible for anticipating/preventing errors whenever possible as each could result in compliance risk, additional costs, and potential delays in overall schedules.
Directly involved in hiring, developing, evaluating, and counseling subordinates. Provide feedback on a regular basis to subordinates and prepare formal performance reviews. Assure subordinates understand and comply with Forest policies and procedures for both Cincinnati and Earth City.
Perform final review and approval of executed manufacturing and packaging batch records and disposition for release. Manage review and release of raw materials, labeling, and packaging components.
Assure accurate and timely completion of all tasks relating to issuance of Change Control, Batch Production Records, Validation, and maintenance of GMP records.
Assure recommended changes from Annual Product Reviews are implemented in a timely fashion.
Manage the site Change Control Program ensuring timely implementation of the approved changes and ensure that all issued controlled documents reflect the currently approved document versions.
Manage GMP record auditing of GMP documents such as equipment logbooks across all operational departments, lab notebooks, and Building Automation System daily and weekly data sets.
Serve as a back-up for the review, approval, and coordination of labeling changes and, as needed, approve orders for purchased labeling.
Assists in hosting GMP related audits conducted by Regulatory agencies, Corporate Compliance, and/or other external parties.
Author, review and approve master documents including, but not limited to, SOPs, Test Methods, Validation Protocols, Validation Reports, Master Batch Records and GPRs.
Prioritize and communicate common objectives with internal and external customers.
Coordinate the implementation of corporate quality standards and policies for Cincinnati and St. Louis.
Assure QA compliance by maintaining robust quality systems, providing necessary training and updating SOPs and/or other controlled documents.
Review quality systems used at Forest Cincinnati and Earth City. Recommend and implement upgrades to improve efficiency, productivity, quality, and compliance including implementation of electronic-base systems for Cincinnati and Earth City.
Ensure data integrity for all aspects of quality assurance inspection documentation.
Communicate effectively to resolve potential conflicts among direct reports and other Forest personnel.
Assist as needed in investigating quality complaints, deviations, and product failure investigations.
Provide an environment of professional growth for QA Associates and the document controller.
Ensure compliance for tasks performed by QA staff.
ADDITIONAL JOB RESPONSIBILITIES:Provide assistance to QA Director and perform other duties as assigned.
Receives assignments in the form of objectives and establishes goals to meet objectives. Provides guidance to subordinates to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting objectives and schedules. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
A minimum of five - eight years experience in pharmaceutical or related industry with a minimum of 3 year Quality Assurance experience in an FDA regulated industry. Previous supervisory experience preferred.LICENSURE/CREDENTIALS:
No special requirements
KNOWLEDGE, SKILLS, AND ABILITIES:
Incumbents must be detail-oriented, have the ability to multi-task, and possess strong organizational and communication skills. The position requires thorough understanding of pharmaceutical cGMP documentation requirements through self directed study using trade publications, the internet, and other informational sources. The position requires proficiency in the use of Microsoft Word, Excel, Access, Power-Point, Outlook and Explorer. Knowledge of electronic systems for batch records and regulatory submissions is desirable.
While performing the duties of this job, the employee is required to Sit for long periods of time and travel to attend training seminars and to other Forest sites.
A bachelor’s degree in biology, chemistry, engineering, pharmacy, or similar scientific discipline.