The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Post : Team Lead, Quality Assurance
Brief Job Overview
This is a supervisory professional position responsible for support to the various activities of Quality Assurance, in coordination with the Senior Manager-QA / Director - QA, other internal departments and international locations to carry out quality objectives and processes as they relate to providing quality systems and metrics for USP. This position is responsible for auditing, document control, reference standard review/release, Conducting Laboratory investigations, CAPAs, supplier evaluations, preparing for external ISO Audits.
• Perform laboratory project documentation audits including Analytical method validation reports independently, issue audit reports and adhere to achieve monthly target. Additionally, perform supervisory review and approval of project reports.
• Review and approval of equipment qualification /calibration/ validation reports associated with Reference Standards development and evaluation. Additionally, review and approval of in-house equipment qualification protocols.
• Conduct internal audits per ISO standards and USP In-house procedures, timely release of audit reports and ensure adequate response to the audit observations.
• Review and approval of quality notifications such as deviation, OOS/OOT, Issue (Incident), Change control, and Corrective and Preventive action (CAPA). Coordinating with CFT (Cross Functional Team) on adequate investigation, RCA, CAPA and timely closure of quality notifications.
• Develop training content and deliver training to staff on ISO standards, Quality topics, QA orientation and applicable in-house procedures.
• Coordinate and support QA and CFT in preparation of external ISO audits (ISO/IEC 17025 and ISO 9001).
• Support in collection, compilation, and evaluation of Quality Management system data for Management review Meeting (MRM).
• Support QA director in achieving departmental quality objectives.
• Review and approval of Vendor registration and evaluation process. Tracking material issues and ensure adequate investigation / CAPA. Conduct vendor audit for critical vendors and ensure compliance to ISO standards and USP supplier evaluation program.
• Review of SOPs, Process / workflows, and guidelines consistent with ISO standard and USP In-house procedures.
• Works with HR and Senior Manager, QA in identifying employee training needs, scheduling, implementation, and verification of the training effectiveness and for coaching and mentoring direct reports.
• Identify and implement appropriate actions for continual improvement of QMS at USP IN based on the trend data analysis and audit findings.
• Adhere and promote USP core values & DEIB (Diversity, Equity, Inclusion and Belonging) within the department and throughout the organization.
• Master’s degree in Chemistry / Pharmacy with around 14 years of relevant experience in a pharmaceutical industry preferably working in Development QA/Analytical Reviewer role/Quality Assurance in API or Finished Dosage Formulations. 3-4 years of supervisory experience is a must.
• Previous working knowledge on analytical testing, bioanalytical testing, microbiology, and synthetic process control management strongly preferred.
• Have thorough understanding of cGMP, GLP, and ISO standards (9001 & 17025) requirement and the integration of the regulations into working systems in the Quality assurance.
• Should possess a fair understanding of USP-NF monographs, general chapters, and General notices.
Additional Desired Preferences
• Strong technical writing, English writing and editorial review and oral communication skills required.
• Strong 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 have proven ability to raise and resolve issues when others are directly accountable for outcomes. Demonstrate ability to build strong, credible working relationships across an organization.
• Sound working knowledge on ISO 9001, ISO 17025 and GMP standards, familiarity and exposure with internal audits. A lead auditor certificate on ISO 9001 (or) ISO 17025 is preferred.
• Strong knowledge of MS office tools such as Word, Excel, and power point presentation.
• Exposure to lab software such as Laboratory Management System (LMS), NuGenesis - SDMS, Waters Empower® would be advantageous.
• Working experience on QA QMS software applications such as MasterControl, MetricStream, Tracwise etc. and metrics would be advantageous.
Experience : 5+ years
Qualification : M.Pharma / M.Sc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : QA
End Date : 30th July, 2023
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