Job Opportunities in India
July 20, 2024
Maya Biotech PVT LTD
Baddi
OTHER & FULL TIME
Quality Assurance (IPQA/ Validation/QMS)
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:
Education:
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., c GMP, 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.
- 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.
Education:
- Bachelor's (Preferred)
- QA: 1 year (Preferred)
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