Senior Quality Specialist - Indiana, United States - Harba Solutions Inc.

Description

Job Responsibilities:

• Lead and manage quality assurance activities within the pharmaceutical manufacturing facility, including but not limited to batch record review, deviation management, change control, and CAPA (Corrective and Preventive Action) implementation.
• Serve as the primary point of contact for regulatory inspections and audits, coordinating preparations and responses to regulatory agencies such as the FDA, EMA, and other global health authorities.
• Develop, implement, and maintain Quality Management Systems (QMS) in accordance with current Good Manufacturing Practices (cGMP) and other relevant regulatory standards.
• Conduct risk assessments and gap analyses to identify areas for process improvement and ensure continuous compliance with regulatory requirements.
• Provide guidance and support to cross-functional teams on quality-related issues, serving as a subject matter expert on cGMP regulations and industry best practices.
• Collaborate with internal stakeholders, including Manufacturing, Quality Control, Regulatory Affairs, and Supply Chain, to drive quality initiatives and ensure alignment with company objectives.
• Lead investigations into quality incidents, deviations, and non-conformances, implementing effective corrective and preventive actions to mitigate risks and prevent recurrence.
• Participate in the review and approval of validation protocols, qualification documents, and regulatory submissions to ensure compliance with regulatory requirements and company standards.
• Mentor and train junior quality assurance staff, fostering a culture of continuous learning and professional development within the quality organization.
• Stay informed of emerging regulatory trends and changes in the pharmaceutical industry, proactively advising management on potential impacts and opportunities for improvement.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biochemistry, or related scientific field.
• Minimum of 5-7 years of experience in quality assurance roles within the pharmaceutical industry, with a focus on manufacturing operations.
• In-depth knowledge of cGMP regulations, ICH guidelines, and other applicable regulatory requirements governing pharmaceutical manufacturing.
• Proven track record of successfully managing regulatory inspections and audits, with experience interfacing with regulatory agencies.
• Strong analytical and problem-solving skills, with the ability to lead complex investigations and root cause analyses.
• Excellent written and verbal communication skills, with the ability to effectively communicate with internal and external stakeholders at all levels of the organization.
• Demonstrated leadership abilities, including the ability to influence and motivate cross-functional teams to achieve quality objectives.
• Detail-oriented with a commitment to accuracy and compliance in all aspects of work.
• Proficiency in using quality management software systems and Microsoft Office applications.
• Certification in quality management (e.g., Certified Quality Auditor, Certified Quality Engineer) is a plus.