Quality Controller

3 months ago


Sonipat, India Akron Healthcare Pvt. Ltd. Full time

**Key Responsibilities**:

- Develop, implement, and maintain quality assurance and quality control processes in accordance with Drug IP, BP, USP, ISO 9001, and ISO 13485 standards.
- Conduct thorough testing and analysis of raw materials, intermediates, and finished products to ensure compliance with specifications and regulatory requirements.
- Review and interpret pharmacopoeial monographs (e.g., Drug IP, BP, USP) to establish testing protocols and specifications for materials and products.
- Perform risk assessments and root cause analysis to investigate deviations, non-conformities, and out-of-specification results, and implement corrective and preventive actions.
- Maintain accurate documentation and records of QA/QC activities, test results, and compliance documentation in accordance with regulatory requirements.
- Participate in internal and external audits, inspections, and regulatory submissions to demonstrate compliance with applicable standards and regulations.
- Provide technical expertise and support to cross-functional teams on quality-related matters, including process improvements, validation activities, and change control.
- Stay updated on industry trends, regulatory changes, and best practices in quality assurance and quality control to enhance the effectiveness of QA/QC processes.

**Requirements**:

- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree preferred.
- Minimum 2 years of experience in pharmaceutical quality assurance and quality control roles, with specific knowledge of Drug IP, BP, USP monographs, and ISO standards.
- Strong understanding of pharmaceutical manufacturing processes, GMP (Good Manufacturing Practice) guidelines, and regulatory requirements.
- Experience with quality management systems, document control, and deviation management.
- Proficiency in conducting analytical testing using laboratory equipment and instrumentation.
- Excellent analytical, problem-solving, and decision-making skills with a focus on continuous improvement.
- Effective communication skills, both written and verbal, with the ability to collaborate with cross-functional teams.
- Quality certifications (e.g., Six Sigma, ISO Lead Auditor) are a plus.

Pay: ₹10,571.01 - ₹34,638.74 per month

Schedule:

- Day shift

Work Location: In person


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