Purpose
To supervise, manage and provide technical support to QC Biological team.
Key Responsibilities Area
Technical Responsibilities
Manages the biological laboratory activities to assure timely availability and accuracy of results.
Reviews and approves all required biochemistry/ microbiological testings for utilities & environmental monitoring, raw materials, manufacturing processes and products and ensures that the tests are analyzed in accordance with corporate, regulatory and external agency regulations.
Enforces all laboratory policies and practices, and ensure that all in-use procedures are current and compliant.
Establishes and maintains safety and security policies and practices.
Supports equipment/software/method validation and performs (re)validation when necessary.
Monitor results and take corrective actions when appropriate.
Provides support and technical expertise to ensure that manufactured products meet applicable regulatory standards and guidelines with respect to QC operations. Ensures expenditures are within budget. Keeps up-to-date on the regulations concerning biopharmaceutical QC activities. Participates in investigation of non-conformities (deviations and exceptions) Leads and participates in GPS initiatives for continuous improvements Problem Solving :
Identifies / reports /resolve / escalate issues promptly and appropriately.
Implement appropriate corrective actions.
Presents in a timely manner major issues to the management strategies on their resolution.
People Responsibilities
Manages the biological team:
Ensures appropriate training and development for the team.
Provides leadership, guidance and technical expertise to the team
Organization and Management
Manages the priority/resources of the biological team.
Creates strong team morale and a culture of accountability and ownership.
Ensures continuous improvements of the QC operations.
Ensures policies on SHESS are deployed and respected.
Skills, Knowledge & Experience
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