Pharmaceutical Quality Specialist

Description

The Pharmaceutical Quality Specialist is responsible for overseeing and managing documentation and processes essential for qualification activities related to pharmaceutical manufacturing and quality processes. This role ensures compliance with regulatory standards (e.g., FDA, EMA, and cGMP) and company policies, ensuring that all quality system documentation and processes meet the highest quality standards. The Pharmaceutical Quality Specialist plays a key role in maintaining product integrity, patient safety, and overall compliance within the organization.

Requirements

Quality Operations:

• Author, review and/or approve procedures, reports, batch records and other necessary documents to support ongoing manufacturing processes that follow regulatory standards.
• Responsible for Quality Operations oversight including real-time batch record review, response to deviations and implementation of corrective actions.
• Provide Quality review and support for calibration and maintenance programs and ensure they are run following GMP regulation.
• Participate in or lead quality risk analysis.
• Responsible for performing quality-based training of operations team members.

Documentation and Compliance:

• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control and management escalation.
• Ensure the correct and prompt creation, review, and maintenance of quality system documents and records.
• Support internal and external audits, inspections, and regulatory submissions.

Validation Management:

• Ensure that all validation activities are conducted in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.
• Lead and manage the validation documentation lifecycle for equipment, processes, facilities, and computer systems in the pharmaceutical environment.
• Review and approve validation protocols (IQ, OQ, PQ) and reports.

Process Improvement:

• Collaborate with cross-functional teams, including Manufacturing, Engineering, and Regulatory Affairs, to identify opportunities for process improvements and enhancements.
• Support continuous improvement initiatives and implement best practices for quality processes.

Stakeholder Collaboration:

• Act as the subject matter expert (SME) for validation and documentation activities during regulatory inspections and internal/external audits.

Experience & Qualifications:

• Minimum of 5-7 years of experience in a pharmaceutical or biotechnology environment.
• Strong knowledge of FDA, ICH and other global regulatory requirements, including cGMP and GAMP5.
• Hands-on experience with qualification and validation of processes, facilities, equipment, utilities, and computerized systems.
• Excellent communication, problem-solving, and organizational skills.
• Proficiency in QMS and ERP software and documentation management systems is a plus.

Education & Certifications:

• Bachelor's or Master's degree in Science, Engineering, Pharmacy, or a related field.

Preferred Qualifications:

• Experience with API or pharmaceutical manufacturing, sterile fill finish and/or biologics.
• Certification in Lean Six Sigma or equivalent process improvement methodologies.
• Familiarity with risk management tools such as FMEA.

Physical Requirements:

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.