The United States Pharmacopeia (USP) is a non–governmental, official public standards–setting authority for prescription and over–the–counter medicines and other healthcare products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years.
Post : Senior Manager, Quality Assurance
Job Description
This is a supervisory position responsible for planning and managing Quality Assurance for USP. The incumbent will collaborate with Director – QA, management, other internal departments, and the international locations to carry out quality objectives and processes as they relate to providing quality systems and metrics for USP. The position is responsible for the development and implementation of robust quality systems for Non-conformances, CAPAs, Auditing, Document Control, Reference Standard Review/Release, Complaint Handling, Supplier Quality, cGMP auditing; and for coaching and mentoring direct reports.
Roles and Responsibilities:
- Perform project documentation audits including CDL-Analytical method validation reports independently and also conduct supervisory review and approval and issue audit reports.
- Review and approve qualification/ validation documents.
- Provide support in preparing Briefing Book and support director QA for Management Review Meeting.
- Review SOPs (standard operating procedures), forms and formats applicable/originated at USP-India.
- Review and approve supplier evaluation dossiers including supplier screening, vendor registration forms.
- Implement and follow Quality Management systems such as deviation, Corrective and Preventive action (CAPA) and document control and assists laboratory investigation report(s) (LIR). Conduct independent investigations and respond to inquiries related to quality issues.
- Conduct internal audits independently/with a team of auditors, prepare reports and assess adequacy of CAPA.
- Conducts cGMP site audits at of dietary supplements, active pharmaceutical ingredient (API), excipient, and dietary ingredient manufacturing sites, according to the appropriate cGMP guidelines and USP program requirements.
- Prepares audit reports in a timely manner summarizing the results of the site audits and makes recommendations to the Director, QA and Senior Director, VER regarding site compliance with cGMP requirements.
- Conduct quality assurance activities in the laboratory area as directed by appropriate ISO standards, internal SOPs.
- Support trending of project documentation audits and identifies the most reoccurring and major issues and propose its correction and corrective action.
- Responsible to organize/conduct training to staff on ISO, Quality topics, QA orientation and in-house procedures
- Coordinate and supports in preparation of external ISO audits (ISO/IEC 17025 and ISO 9001).
- Prepare weekly/fortnightly dashboards and monthly reports and keep track of audit observation trends, CAPAs, Deviations, LIR and other QA activities.
- Represents QA as the lead or support in process improvement teams or initiatives and provides suggestions for appropriate quality system improvement tools.
- Adhere and promote USP core values within the department and throughout the organization.
Required Skills
- Excellent technical writing, English writing and editorial review and oral communication skills required.
- Excellent problem solving and auditing skills are required.
- Must be able to communicate effectively with customers and third parties and diverse audiences at all levels of an organization.
- Must be a solid independent thinker with demonstrated ability to discern multiple viewpoints. Ability to complete work assignments and achieve results on time and within budget.
- Must have proven ability to raise and resolve issues when others are directly accountable for outcomes. Demonstrated ability to build strong, credible working relationships across an organization.
- Must have sound working knowledge on ISO 9001, ISO 17025 and GMP standards, familiarity and exposure with internal audits, external GMP audits required.
- Working knowledge of computer applications, such as MS Word and MS Excel and exposure to lab software such as e-LNB, NuGenesis, and Empower would be advantageous.
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Required Experience
- Master’s degree in Chemistry / Pharmacy/ Biotechnology / Bio-Chemistry and 10-12 years of relevant experience in a pharmaceutical industry preferably working in API or finished formulations, with minimum of 2-3 years of supervisory experience on expected jobs in quality assurance.
- Knowledge on analytical testing is preferred.
- The incumbent must have thorough understanding on GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the Quality Assurance.
- Should possess a fair understanding of USP’s monographs/ general chapters/ general notices.
Additional Information:
Experience: 10-12 Years
Location: Hyderabad, Andhra Pradesh
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 15th July, 2017
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