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Responsibilities:

• Provide QA review and approval for establishment of standardized global procedures and training to the NQC teams standardizing Laboratory Data Systems (LDS) and Equipment Qualification and Software Validation.
• Review and approve QC instrument qualification and software validation documentation, including any associated deviations ensuring root cause and robust CAPAs have been identified.
• Review and approve global procedures at local sites considering existing local site CAPAs and procedures.
• Support inspection/audit readiness activities related to network documentation.
• Review and approve select, key multi-site and network deviations concerning laboratory methods.

Requirement:

• Minimum of 5 years' experience in the (bio) pharmaceutical industry, with at least 2 years within a QA role.
• In depth knowledge of cGMP regulations pertaining to instrument qualification, computer system validation and QC operations. Knowledge of 21CFR part 11, EU Annex 11 and GAMP regulations is desirable.
• Data analysis to identify trends and their root causes.
• Self-directed with a high degree of professional integrity, organization, and attention to detail.
• Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
• Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
• Matrix team leadership a strong preference.
• Innovative problem solving and growth mind-set is a strong preference.