Change Control Manager

SV MANAGEMENT CONSULTANTS
  • Visakhapatnam
  • 10-15 lakh
  • 5-8 years
  • 103 Views
  • 29 May 2015
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  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Responsibilities include administration and oversight of the site change control process as defined in the relevant site standard operating procedures. Develop succession planning for the Quality Unit.

Responsibilities -
1.Accountable for ensuring that change made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems.
2.Manage the change control process.
3.Conduct CCB (Change Control Board) meetings.
4.Review the change package to ensure the requirements site change control procedure are met, Good Documentation Practices (GDP) are followed, and all required sections have been completed.
5.Monitor the status of change packages.
6.Monitor Change control management and review the monthly data on change control status.
7.Review and approve of metrics for Change Controls and Documentation and associated CAPAs. Provide Change control matrices status for site quality management review meeting.
8.Review and approve corporate change control.
9.Communicate to change owners, sites, regions, and functions after change package is closed.
10.Assist in the implementation of QA Documentation policies and procedures.
11.Provide guidance to change owner throughout the change process asrequired answering questions and resolving issues.
12.Drive continuous improvement of change process to maintain compliance and improve efficiency.
13.Develop and implement tools and guidelines that will improve the change control systems.
14.Coordinate impact assessment with team members
15.Assist Quality System Head for day to day operations.
16.Adherence to Safety Procedures/GMP & GDP Practices.



Technical Skills -
1.Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations
2.Detailed knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines.
3.Well versed with Change management process.

Standards, Processes and Policies -
Knowledge of GMPs and regulations governing manufacturing operations for sterile products including aseptic processing.

Behavioral / Any other Skills -
1.Excellent attention to detail.
2.Demonstrated leadership skills; ability to use initiative and drive to achieve results.
3.Strong interpersonal skills.


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SV MANAGEMENT CONSULTANTS