
Quality Assurance Executive
2 days ago
Job Description: Quality Assurance ExecutivePosition Title: Quality Assurance ExecutiveLocation: Manchar, Pune (Lactose)Job Summary: We are seeking a skilled and experienced Quality Assurance Executive with a strong background in the pharmaceutical industry to join our team at our Manchar, Pune location. The ideal candidate will possess technical expertise in the pharma industry, regulatory compliance, FDA certification mandates, and quality assurance processes. This position is crucial in supporting our production team and ensuring that all pharmaceutical products meet the required standards for safety, quality, and efficacy.
Key Responsibilities:Assist in the development and maintenance of pharmaceutical formulations, ensuring they meet industry standards and regulatory requirements. Review and verify all documentation related to product development, regulatory submissions, and approvals. Support in the government approval process for pharmaceutical products.
Ensure adherence to FDA guidelines and certification requirements. Perform quality assurance checks and reviews of raw materials, in-process materials, and finished products. Conduct tests, evaluations, and data analysis related to product quality and safety.
Work closely with the QA team to implement and maintain standard operating procedures (SOPs) and ensure product consistency and quality. Monitor the manufacturing processes and assist in troubleshooting any production issues. Prepare and maintain reports related to product quality and regulatory compliance.
Assist in managing product stability studies, validation processes, and documentation of results. Coordinate with cross-functional teams, including regulatory affairs and production departments, to meet quality and compliance standards. Qualifications:Education: BSC / MSC in Pharmacy or equivalent.
Experience: Minimum of 2+ years of experience in the pharmaceutical industry, with a focus on regulatory compliance, documentation, FDA certification, and quality assurance. Strong knowledge of pharmaceutical manufacturing processes, regulatory guidelines, and industry best practices. Excellent technical knowledge related to the quality assurance of pharmaceutical products.
Understanding of government approval processes for pharmaceutical products. Proficiency in documentation and preparation of reports in accordance with industry standards. Skills and Competencies:In-depth understanding of FDA regulations and quality standards.
Strong analytical and problem-solving skills. Attention to detail and a commitment to maintaining high standards of quality. Strong communication and interpersonal skills to work effectively with cross-functional teams.
Ability to work independently and efficiently in a fast-paced environment. Familiarity with QA processes, audits, and compliance procedures. Preferred Industry:Pharmaceutical industry (Lactose manufacturing experience is a plus).
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