Job Description

Position Overview:

We are seeking an experienced Quality Assurance professional with 4 to 8 years of relevant industry experience to join our pharmaceutical company in a pivotal role focusing on Validation & Qualification, In-Process Quality Assurance (IPQA), Quality Management System (QMS) Review, and Documentation for injectable products. This position is critical for ensuring compliance with regulatory standards and maintaining high-quality standards throughout our manufacturing processes.

Key Responsibilities:

• Validation and Qualification:
• Lead and execute validation and qualification activities for equipment, processes, and systems specific to injectable manufacturing.
• Develop and review validation protocols, reports, and risk assessments, ensuring compliance with regulatory requirements.
• Maintain comprehensive validation documentation and ensure adherence to established timelines.
• In-Process Quality Assurance (IPQA):
• Implement robust IPQA strategies to monitor and assure the quality of injectable products during all manufacturing stages.
• Conduct regular inspections, audits, and sampling of in-process materials to identify and address deviations promptly.
• Collaborate closely with manufacturing teams to uphold adherence to SOPs, GMP guidelines, and quality standards.
• Quality Management System (QMS) Reviewer:
• Evaluate the effectiveness of the QMS for injectable manufacturing, including SOPs, policies, and documentation.
• Conduct internal audits to assess compliance with regulatory standards (e.g., cGMP, ISO) and company procedures.
• Lead and support initiatives for continuous improvement, including CAPA implementation and quality metrics analysis.
• Documentation:
• Manage and maintain accurate documentation related to validation, IPQA, and QMS activities for injectable products.
• Ensure documentation complies with regulatory guidelines and is readily accessible for audits, inspections, and regulatory submissions.
• Develop, review, and update SOPs, work instructions, batch records, and other quality-related documentation as needed.
• Collaboration and Training:
• Collaborate effectively with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs to drive quality initiatives and resolve quality-related issues.
• Provide mentorship, training, and guidance to junior QA team members and manufacturing personnel on quality assurance principles, practices, and procedures.

Qualifications & Skills :

• Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field;
• 4 to 8 years of progressive experience in Quality Assurance within the pharmaceutical industry, with a focus on injectable products.
• In-depth knowledge of regulatory requirements and guidelines applicable to injectable manufacturing (e.g., FDA 21 CFR Part 210/211, EU GMP Annex 1).
• Proven experience in leading validation activities (IQ/OQ/PQ) and proficiency in statistical analysis tools.
• Strong analytical skills with a detail-oriented mindset and the ability to effectively manage multiple projects and priorities.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively in a team environment.

Job Types: Full-time, Permanent

Education:

• Bachelor's (Preferred)

Experience:

• QA: 1 year (Preferred)

Work Location: In person