Quality Assurance Specialist
7 days ago
Prestige Biopharma Limited is a leading pharmaceutical company dedicated to delivering high-quality products that meet the evolving needs of our customers.
Job Description
We are seeking an experienced Quality Assurance Specialist to join our team. The successful candidate will be responsible for implementing and maintaining quality management systems, ensuring compliance with regulatory requirements, and driving process improvements across our bioprocessing operations.
Key Responsibilities:
- Implement quality management systems in accordance with cGMP and international regulations.
- Update complaints and escalate issues into the CAPA system as needed.
- Participate in product quality activities by reviewing test protocols, reports, and analytical data.
- Review OOS investigations, deviations, CAPA, and risk management for products.
- Draft and review quality technical agreements.
- Provide management with quality data and trends.
- Perform internal audits to ensure effective implementation of quality management systems.
- Audit CMOs to ensure compliance with guidelines, regulations, and agreements.
Requirements:
Education/Qualification:
- Bachelor's degree in Engineering (Biomedical) or Science (Biology, Chemistry, Bio-engineering).
- Minimum 2-3 years of experience in pharmaceutical quality assurance, with a focus on product quality management and compliance.
Skills and Qualifications:
- Strong analytical and problem-solving skills.
- Good computer skills and adaptability to technology.
- Results-oriented, multi-tasking, quick learner.
- Excellent communication and collaboration skills.
- Proven track record in conducting audits, investigations, and implementing corrective actions.
Salary Range:$80,000 - $110,000 per annum depending on experience.
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