Browse Jobs
For Employers
Post JobLog inGet Started

Quality Assurance Manager

2A Pharma
6th of October, Giza
Posted 4 years ago
67Applicants for1 open position
  • 43Viewed
  • 1In Consideration
  • 0Not Selected
Search other opportunities

Job Details

Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:

Skills And Tools:

Job Description

Primary Responsibilities

  • Utilize a high degree of independent judgment and decision-making to direct quality personnel to ensure manufacturing schedules and customer supply requirements are achieved
  • Management of qualifications, re-qualifications, routine monitoring and per-process monitoring of the facilities, utilities, and personnel, as required.
  • Ensure all actions are performed per the required schedule and/or business need
  • Manage the ongoing trending program for Utility Systems and Classified Areas including evaluating data for adverse trends
  • Providing summaries of test results to appropriate personnel as needed
  • Development and management of the Risk-Based Incursion Process
  • Management of Out of Specification results and required actions by Operations and Quality
  • Management for submission of samples in the Global Laboratory Information Management System (GLIMS)
  • Compiles and approves Environmental and Utility Annual Review
  • Provides direct oversight for the Process Simulation program to include at a minimum program definition, protocol development, monitoring of execution and final report closure
  • Develops, edits, writes, reviews and approves departmental SOPs and investigations
  • Ensures that all SOPs and documentation associated with these programs are maintained and adhered to
  • Manage adherence to departmental Quality metrics
  • Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes
  • Performs other duties as assigned
  • People Management / Leadership
  • Applies management skills to align staff activities with department objectives
  • Provide leadership to the Quality team including coaching, development, and performance management
  • Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations within the team and site
  • Provide mentorship and training to team and peers
  • Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables
  • Adapts and implements departmental plans and priorities to address local business, service and operational challenges. Supports the achievement of plant objectives (e.g., metrics, productivity)
  • Manages area in accordance with company policy and applicable government regulations.
  • Makes provisions to assure the job responsibilities of the area are conducted in a timely and reliable manner to meet production demands. Accountable for the performance of workgroup
  • Responsible for the necessary personnel and equipment resources to ensure that customer expectations are met or exceeded. Forecasts resource needs and aligns resources with business unit needs
  • Responsible for knowledge of current Good Manufacturing Practice (cGMP) and safety requirements, as well as the transfer of that knowledge to employees
  • Routinely makes decisions that impact the unit’s ability to meet performance objectives using cGMP and safety knowledge as a guide
  • Manages activities to identify and correct problems, emphasizing prompt and definitive resolution to minimize adverse impact and reoccurrence
  • Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes. Reports to the Associate Director for general advice and instruction, but normally handles routine matters independently, consulting on major problems only
  • Responsible for administrative and personnel actions such as hiring, transfers, training, salary and appraisal administration
  • The incumbent assures that all subordinates are being developed to provide a resource for future growth and opportunities within the site or company
  • Applies leadership principles to all actions
  • Performs the duties and responsibilities of the Associate Director in his/her absence, as required

Cost

  • Ensure that activities are carried out in accordance with departmental budget
  • Recognize and implement opportunities for efficiency and financial savings
  • Provides shop floor related input to departmental budget and recommends continuous improvement opportunities and capital projects for the IPT
  • Continuous Improvement
  • Partner with Technology, Op

Featured Jobs

Similar Jobs

Search other opportunities
JobsBusiness DevelopmentQuality Assurance Manager