Assistant Manager - Quality Assurance (Injectables / Sterile)

Title: Assistant Manager / Senior Executive - Quality Assurance (Validation)

Company:

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Experience:

Educational Qualification:

Job Summary:

The AM/ Sr.Executive - QA (Validation) will be responsible for overseeing the development, implementation, and maintenance of validation processes within the sterile injectable and vaccine manufacturing environment. This role ensures all validation activities comply with regulatory requirements and industry standards, contributing to product quality and operational excellence.

Minimal Qualification Requirements:

• MSc in Microbiology/Biotechnology, B. Pharm, or B.Tech with 5-8 years of experience in vaccine biologicals and injectables
• Strong experience in sterile injectable facilities
• In-depth knowledge of validation for clean rooms, HVAC systems, water systems, and process equipment
• Strong understanding of regulatory requirements for validation activities (e.g., FDA, EU, WHO)

Key Responsibilities:

1. Oversee the development, review, and approval of validation protocols and reports.
2. Develop and implement quality assurance (QA) strategies for validation activities.
3. Ensure validation activities are conducted in compliance with regulatory requirements (e.g., FDA, EU, WHO).
4. Ensure adherence to 21 CFR Part 11, EU GMP Annex 15, and other relevant regulatory guidelines.
5. Provide expert guidance on regulatory requirements related to validation processes.
6. Develop and deliver comprehensive training programs for QA validation staff.
7. Identify areas for continuous improvement in QA validation processes and implement best practices.

Skills and Competencies:

• Strong knowledge of validation principles for sterile environments and pharmaceutical equipment
• Expertise in regulatory compliance, including FDA, EU GMP, and WHO guidelines
• Proficient in drafting and reviewing validation protocols and reports
• Strong analytical, problem-solving, and risk assessment skills
• Excellent communication and interpersonal skills for cross-functional collaboration
• Ability to manage multiple validation projects effectively
• Commitment to continuous improvement and quality excellence

About GreenSignal Bio Pharma Pvt Ltd:

GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company dedicated to delivering quality healthcare solutions, with a strong focus on vaccine manufacturing and biological products. Our commitment to innovation, compliance, and operational excellence drives our success.

For more information, please visit our website: www.gsbpl.com

How to Apply:

hr@gsbpl.com

73055 21762

Apply Now to join our team and contribute to impactful pharmaceutical and vaccine innovations!