
Quality Specialist III - APQR
Are you passionate about ensuring quality and compliance in the pharmaceutical industry? Do you have a strong understanding of regulatory guidelines and experience with annual product quality reviews (APQR)? If so, we have an exciting opportunity for you to join our team as a Quality Specialist III - APQR at Teva Pharmaceutical USA.As a Quality Specialist III, you will play a crucial role in maintaining the highest standards of quality and compliance for our products. Your expertise in APQR will be essential in conducting thorough reviews and identifying areas for improvement in our processes and products. You will work closely with cross-functional teams to implement corrective actions and drive continuous improvement.To excel in this role, you must have a minimum of 5 years of experience in quality assurance or related field in the pharmaceutical industry. A strong understanding of regulatory requirements, including FDA, ICH, and EMA guidelines, is a must. In addition, you should have excellent communication and problem-solving skills, as well as a keen attention to detail.If you are looking for a challenging and rewarding career in the pharmaceutical industry, we encourage you to apply for our Quality Specialist III - APQR position. Join our team at Teva Pharmaceutical USA and make a difference in the lives of patients worldwide.
- Conduct thorough reviews of annual product quality reports (APQR) to ensure compliance with regulatory guidelines and identify areas for improvement
- Collaborate with cross-functional teams to implement corrective actions and drive continuous improvement in quality and compliance
- Stay updated on regulatory requirements and guidelines, including FDA, ICH, and EMA, and ensure all processes and products are in compliance
- Communicate effectively with various stakeholders, including internal teams, external partners, and regulatory authorities
- Provide guidance and support to other team members on quality and compliance matters, including APQR
- Participate in audits and inspections by regulatory authorities and assist in addressing any findings or observations
- Analyze data and trends to identify potential issues and develop strategies to prevent quality and compliance issues
- Develop and maintain standard operating procedures (SOPs) related to APQR and ensure their adherence
- Train and educate team members on quality and compliance requirements, including APQR guidelines
- Conduct risk assessments and develop risk mitigation plans for quality and compliance issues related to APQR
- Participate in cross-functional projects and initiatives to improve overall quality and compliance within the organization
- Maintain accurate and up-to-date documentation related to APQR activities and ensure data integrity and traceability.
Minimum Of 5 Years Of Experience In Quality Assurance Or Quality Control Within The Pharmaceutical Industry.
Bachelor's Degree In A Scientific Or Engineering Field, Such As Chemistry, Pharmacy, Or Chemical Engineering.
Knowledge And Understanding Of Fda Regulations And Guidelines, Including Cgmp, Glp, And Ich Guidelines.
Strong Analytical Skills And Attention To Detail, With The Ability To Identify And Troubleshoot Quality Issues.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Communicate Complex Information To Diverse Audiences.
Risk Management
Quality Assurance
Change Management
Data Analysis
Quality Control
Root Cause Analysis
DOCUMENT CONTROL
Regulatory compliance
Training and Development
Audit Preparation
Gmp Standards
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Quality Specialist III - APQR in Bengaluru, Karnataka, India is between Rs. 6,00,000 to Rs. 10,00,000 per year. This may vary depending on the specific company, experience level, and skills of the individual.
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Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S. Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC).

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