Post : Associate QA Director
Job Description
• Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
• Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
• Manage allocation of QA&C staff within local region to complete the required audits and fulfill staff utilization/achievement of QA&C targets
• Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
• Provide local /regional leadership and line management as required.
• University/college degree, BA/BS (life science preferred) or equivalent experience Preferred
• Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or Equivalent experience
• Excellent technical knowledge, understanidng an experience applying ICH/FDA / Good Clinical Practices
• Strong analyticial skills
• Excellent oral, written and presentation skills
• Excellent planning and organizational skills
• Proven interpersonal skills
• Demonstrated ability to handle multiple competing priorities across clinical operating units
• Ability to inspire effective teamwork and motivate staff within a matrix system
• Ability to function as a member of a global clinical team
• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
• Financial understanding of global clinical development budgets
Experience
• 4 years’ experience in Clinical Quality Assurance, preferably with GCP experience
• 7 years’ experience in other professional roles within pharmaceutical/CRO environment.. Other required work-related experiences
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
• 4 years’ experience in Clinical Quality Assurance, preferably with GCP experience
• 7 years’ experience in other professional roles within pharmaceutical/CRO environment.. Other required work-related experiences
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Knowledge of the drug development process from the perspective of a contract research organization
Additional Information:
Experience : 4-7 years
Qualification : Graduate, Masters
Industry Type: Pharma
Functional Area: Quality Assurance
Job Number : 2018-18715
End Date : 5th June, 2018
Experience : 4-7 years
Qualification : Graduate, Masters
Industry Type: Pharma
Functional Area: Quality Assurance
Job Number : 2018-18715
End Date : 5th June, 2018
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