The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post: Director, Quality Assurance
Job Description
Summary of the Position:
This is a supervisory and professional position. The incumbent will head the Quality Assurance department of USP India site and will oversee all activities of Quality Assurance. Would work closely with all functional heads and department heads in maintaining effective Quality Management systems and ensure nil conformances in all ISO Audits (9001 & 17025).
Roles and Responsibilities:
- Reviews and supervises QA activities including Project Audits, Process Audits, Method Audits , Document Controls, Equipment Qualifications & validations etc.
- Ensure that all audits are conducted as per schedule and reports issued to stakeholders in line with company requirements.
- Ensure that findings of all audit reports are tracked in the company’s official database and periodic follow up is made with stakeholders to ensure timely corrective and/or preventive actions.
- Periodic review of processes at site and recommend opportunities for improvements
- Co-ordinate revision/preparation of Standard Operating Procedures in line with company requirements and monitor compliance
- Coordinate with Global QA team and implement best practices
- Co-ordinate ISO 9001& ISO 17025 audits and ensure that there are no non conformances
- Conduct training for staff on QA related matters and drive Quality agenda across the organisation
Minimum Requirements:
Education and Experience:
Master’s degree in Chemistry/Pharmaceutical sciences with 15-20 years of relevant experience in pharmaceutical industry
Knowledge, Skills and Abilities:
• Good understanding of GMP, cGMP, GLP, and ISO regulations and integration of the regulations into working systems in laboratory environment.
• Knowledge in regulatory affairs and interpretation of guidelines, audit procedures, documentation, and departmental policies and procedures.
• Exposure to regulatory audits and ability to teach/conduct training programs on quality related matters would be desirable.
• Understanding of proficiency testing as it relates to ISO 17025
• Excellent communication, problem solving and influencing skills is essential.
• Good working knowledge of MS Word, Excel, PowerPoint and Access.
• Effective and efficient project management experience and CMC (chemistry, manufacturing and control) submission experience is desirable.
Supervisory Responsibilities:
Supervises and guides Managers and staff in QA department. Finalizes and signs off on their annual goals and tracks performance on a periodic basis. Lives the core values of USP and sets an example for team members with absolute compliance of Code of Ethics.
Additional Information:
Experience: 15-20 years
Tracking Code: 323-679
Location: Hyderabad, Andhra Pradesh, India
Education: Master’s degree in Chemistry/Pharmaceutical sciences
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: QA
End Date: 28th May, 2015
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