Description
We are looking for someone who has been working within quality systems for atleast 5 years. This position needs someone who is comfortable implementing (MasterControl) and maintaining quality systems. This is a midsize company who is currently in phase III trials and will be going commercial in the US by 2014, so it is a very exciting time to join.General Position Summary:
Performs and maintains critical quality systems (e.g., non-conformances, corrective and preventative actions, investigations, training, and metrics) as they relate to the manufacture, analytical testing, and supplier audits of clinical drug substances and drug products manufactured at CMOs as well as in-house activities.
Key Accountabilities/Core Job Responsibilities:
- Responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance.
- Provide hands-on ownership for the various elements of the quality system to ensure successful performance during third-party audits and regulatory inspections.
- Assist with Quality investigations.
- Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific procedures.
- Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.
- Lead the program for developing and justifying meaningful quality system metrics and provide regular updates to Quality management.
- Administer GXP training and ensure the program meets relevant regulatory requirements.
- Initiate updates and creation of new functional SOPs as required.
- Serves as Quality representative for regulatory inspections as needed.
Please respond for more information.
To find out more about Real please visit www.realstaffing.com