Quality Assurance Compliance Specialist

Job Title: Quality Assurance Compliance Specialist

Key Responsibilities:

• We are seeking a detail-oriented Regulatory Compliance Specialist with 10-15 years of experience in quality assurance and compliance in a pharmaceutical industry setting to join our team.
• The ideal candidate will have expertise in validation methodologies, regulatory guidelines (US FDA, cGMP), and sterile injectable manufacturing processes and aseptic techniques.
• This role requires strong analytical and problem-solving skills, effective communication and documentation skills, and the ability to manage cross-functional teams and prioritize tasks.
• In this position, you will be responsible for reviewing QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.
• You will also review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.
• Additionally, you will handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.
• You will review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.
• Furthermore, you will review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance.
• This role also involves conducting remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements.
• You will manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports.
• Furthermore, you will handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments.
• You will support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence.
• Lastly, you will monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports for management.

Requirements:

• Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field is required.

Skills and Competencies:

• In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques is essential.
• Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.) is crucial.
• Strong analytical and problem-solving skills are necessary.
• Effective communication and documentation skills are vital.
• Ability to manage cross-functional teams and prioritize tasks is required.
• Proficiency in QMS tools and software is essential.

Join our team of dedicated professionals who share your passion for quality assurance and compliance.

Benefits:

• Competitive salary
• Opportunities for professional growth and development
• A collaborative and supportive work environment

About Us:

• We are a leading pharmaceutical company committed to delivering high-quality products and services to our customers.