Responsible for the daily Quality Assurance management, direction and coordination of technical quality functions. Reasponsible for review, approval and release of all components, raw materials and finished pharmaceutical products. Ensures compliance with quality, budgetary, safety standards. Ensures compliance of departmental procedures and work instructions according to cGMPs. Provides training to department employees. Responsible for implementation of testing and in-process monitoring systems to ensure process control.
Approved and review BMRs (Batch Master Records), SOP (Standard Operating Procedures), Work Instructions, Validation protocols, and reports.
Investigate deviations and OOS from both operations and QC laboratory.
Attend production planning meetings, shipping requirements and provide floor support to sustain operations.
Responsible for the management of the Quality Management System (QMS), including the following programs, CAPA, Change Control, Investigations, Complaints and Annual Product Reviews.
Oversees and ensures area policies are consistent with company policies and manages the application and administration of such policies in quality assurance operations in conformity with cGMPs. Implements special project work as required and builds applicable teams to meet project goals.
Directs and co-ordinates the activities of subordinate supervisors, trainers, and QA employees through the development of valid performance plans to ensure timely manufacture and packaging of products is consistent with objectives. Establishes short-term performance goals, training plans, and monitors results to reflect a changing environment. Provides and coordinates scheduling and manpower availability. Develops trains and motivates subordinate personnel, including supervisory team members to maximize job performance. Establishes, maintains, and analyzes the elements of the Quality Management System, documentation procedures and controls to assure departmental compliance with cGMPs.
Prepares weekly, bi-weekly and monthly QA status reports as directed by Senior Quality Assurance management. Investigates and prepares reports on technical manufacturing and packaging operations or distribution activities.
Ensures that all components and raw materials are inspected, sampled and tested according to Quality standards and specifications through daily review and approval of appropriate Quality Assurance records. Oversees routine internal audits of quality management systems.
Establishes and maintains safety Quality Assurance environments and processes in compliance with regulatory, cGMP and company policies. Conducts and participate in safety programs with subordinates. Establish and maintain adequate personnel responsibilities and sanitation programs to meet employee and product safety requirements and good manufacturing practices. Maintain an effective audit program to assure safe and sanitary conditions throughout the facility.
Strong ability to motivate others through forward looking practices in the quality field. Knowledge of employee practices, principles, state and federal employment laws relating to key areas of responsibility. Analysis, reporting, communication, presentation, customer focus and relationship building a must. Intermediate MS Office and Lotus Notes experience necessary. Ability to work with cross-functional teams and departments to resolve quality issues and projects.
This job requires a minimum 10 years of cGMP experience in the pharmaceutical or medical devices industry, preferably in the Quality Assurance, Quality Control or other scientific aspects within the pharmaceutical manufacturing environment.
Minimum BS/BA degree in any life sciences field (Pharmacology, Biology, Microbiology, Chemistry, Biochemistry, Physics, Engineering, etc.) preferred. Specific background and experience may be substituted for the degree requirement.