Senior Quality Process Validation Specialist

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About the role

Responsible for developing and implementing quality process validation strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to design and execute validation plans, including risk assessments and data analysis. Lead the validation team in ensuring that all processes meet established quality standards.

Responsibilities

• Develop and implement quality process validation strategies to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to design and execute validation plans, including risk assessments and data analysis.
• Lead the validation team in ensuring that all processes meet established quality standards.
• Conduct root cause analyses and develop corrective actions to address non-conformities identified during validation activities.
• Prepare and present validation reports to stakeholders, including senior management and regulatory authorities.

Requirements

• Bachelor's degree in a relevant field such as Biotechnology, Chemistry, Engineering, or a related discipline.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical industry, with a focus on process validation and quality assurance.
• Experience with regulatory guidelines and standards, such as FDA cGMP, ICH guidelines, and EMA regulations.
• Strong knowledge of statistical process control (SPC), GxP documentation, and data management systems.
• Excellent communication and collaboration skills, with the ability to work effectively in a team environment.
• Proficiency in Microsoft Office Suite, particularly Excel and PowerPoint.

Qualifications

• Knowledge of Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
• Experience with process analytical technology (PAT) and advanced analytical techniques.
• Ability to manage multiple projects simultaneously and prioritize tasks based on criticality and urgency.
• Experience with Six Sigma methodologies and Lean principles.

Skills

• Strong problem-solving and analytical skills.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency in statistical software such as Minitab or JMP.

Benefits

• Competitive salary commensurate with experience.
• Flexible work schedule with remote work options available.
• Health insurance, dental, and vision coverage.
• 401(k) retirement plan with company match.
• Professional development opportunities and training programs.
• Employee recognition program and wellness initiatives.

Pay

Salary is competitive and commensurate with experience.

Schedule

Full-time position with flexible working hours.

Note: This position is open to candidates located within commuting distance of our headquarters in [City, State].