Sr. Quality Assurance Validation Specialist - Berkeley, CA

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Sr. Quality Assurance Validation Specialist - Berkeley, CA 

Sr. Quality Assurance Validation Specialist - Berkeley, CA

PURPOSE

Quality Control Support SME to provide quality oversight for the Qualification and Validation of the Quality Control Laboratories. Subject matter expertise in analytical Instrument qualification, method development, method validation, method transfer and continued maintenance. Also assists in maintaining validation program up to date with current regulations and industry trends. Perform quality review and approval of qualification & validation documents and related process and procedures. Influence and provide guidance to internal partners on SOPs , best practices, compliant processes and the related documentation SME for 21 CFR Part 11, ICH.

YOUR TASKS AND RESPONSIBILITIES

• Provides QA oversight for validation lifecycle requirements of Quality Control Laboratories with minimum supervision;
• Review and approve QC method validation documents, which may include development and periodic review to demonstrate ongoing maintenance of validation status;
• Review and approve validation documents for QC equipment (analytical Instruments) for commissioning, qualification and validation activities: Documents may include: impact assessment, URS, Risk Assessment, DQ, IQ, OQ and PQ;
• Assist with alignment of local procedures and practices with Corporate and regulatory requirements.  Documents may include:
• Validation Plans, Validation Master Plan, and Validation SOPs. Be able to identify compliance issues, conflicting requirements, inefficiencies or improvement opportunities in our procedures, processes and practices; lead discussion and drive the remediation to completion;
• Resolve and approves validation discrepancies. Also, participates in discrepancy investigations related to validation failures and assess changes to methods and equipment for validation and quality impact;
• Provide SOP oversight for QC method and operational SOPs. Approve SOPs;
• Provide project team leadership including: planning and facilitating team activities. Supervises contractors as needed;
• Utilize in-depth knowledge on GMP quality systems to support assessment of critical issues and  impact of validation on different elements of quality system and risks to product quality. Be able to present the site validation program and strategy during internal and external audits.

Bayer is seeking an incumbent who posesses the following atributes:

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Chemistry or Scientific Discipline. 
• Minimum 8 years of overall experience Pharmaceutical and/or Biotechnology validation or an equivalent combination of education and experience;
• Validation quality assurance and compliance expert with knowledge of compendia, industry guidance and regulatory requirements. For example:
  • ICH / ISO / ISPE / PDA Technical Reports and CFR and international validation requirements;
• Strong background in analytical instrument and test method validation;
• Validation knowledge and ability to accurately review and approve documents to ensure regulatory compliance;
• In-depth knowledge of risk-based approaches to validation;
• Ability to set validation strategy for complex systems and execute validation plans and to drive them to completion;
• Strong written and verbal skills;
• Good Manufacturing Practice (GMP) documentation experience;
• Demonstrated str