Long term hourly rate contract for an experienced Computer Systems Specialist with a strong background in Quality Assurance (QA) and Manufacturing Execution Systems (MES).
- Key Responsibilities:
- Provide Quality leadership, direction, and governance for MES and MES related systems.
- Investigate and troubleshoot issues relating to MES and MES related systems.
- Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility.
- Approve appropriate quality-related documents.
- Provide Quality direction and oversight for MES systems.
- Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.
- Contribution to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.
- Assure consistent implementation of standards across the Quality System.
- Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.
- Interpretation and application of emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.
- Assess the Quality Impact of quality events associated with the area(s) of responsibility.
- Review and approval of change controls, deviations, failure investigations, if applicable.
- Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to the area of responsibility.
- Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.
- Skills, Attributes & Experience:
- BSc, MSc or PhD in Chemistry, Engineering, or related discipline
- 4-5+ years experience working within pharmaceutical or biotech is desirable
- Experience working in cross functional teams and proven ability in decision making.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
- Strong understanding of Data Integrity and its applications
- Self-motivated, positive and ability to work under pressure.
- Demonstrates flexibility and adaptability to meet business needs.
- Demonstrates a continuous improvement mind-set.
- Demonstrated initiative - able to work proactively without direct supervision, continuous improvement mind-set.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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