Senior Specialist Validation
Your tasks and responsibilities
The primary responsibilities of this role, Senior Specialist Validation, are to:
- Provide 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;
Who you are
- 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 approve validation discrepancies;
- Also, participate 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;
- Supervise 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.
WHO YOU ARE
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- Bachelor's Degree in Chemistry or Scientific Discipline;
- Minimum eight 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 required;
- 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 strong interpersonal skills and ability to lead teams;
- Knowledge of best practices in the industry for development engineering standards for pharma / biotech design / construction / operation / maintenance.
- An advanced degree;
- Some cleaning, process, equipment/system, utilities, facilities, SIP, temperature mapping validation experience is desired;
- Computer systems validation experience is desired;
- Prior experience with SPC is desired.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.