The U.S. Pharmacopeial Convention (USP) is a scientific non-profit 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 : Manager Quality Assurance
Summary of the Position
This is a supervisory position responsible for planning and management of various activities of Quality Assurance, in coordination with the Senior Manager-QA and Director - QA, other internal departments including the international locations. This position is responsible for the management of internal and external audits, document control, review and supervisory approval of reference standard test reports, Analytical method validation reports, qualification and validation reports of instruments, Laboratory investigations, CAPAs, supplier evaluations, preparation and review of SOPs as they relate to quality systems and metrics for USP.
Roles and Responsibilities
• Conduct project documentation reviews of Reference Standard Laboratory (RSL) test reports, Compendial Development Laboratory (CDL)-Analytical method validation reports, Synthetics and Analytical development reports independently and also conduct supervisory review/approval and issue the audit reports.
• Ensure the timely completion of project documentation audits, Method audits, Process audits, and facility audits and provide guidance to direct report/team members.
• Review and approve qualification /calibration/ validation reports of equipment used in the evaluation of Reference Standards, compendial development.
• Conduct internal audits independently/with a team of auditors, prepare reports and assess adequacy of CAPA.
• Conduct reviews of qualification protocols, SOPs, as directed by relevant ISO and internal SOPs.
• Plan and lead quality improvement activities based on data analysis and audit findings by working closely with laboratory and process owners.
• Review and approve supplier evaluation dossiers including vendor registrations, conduct supplier audits.
• Implement and follow Quality Management systems such as deviation, Corrective and Preventive action (CAPA) and document control and assists laboratory investigation reports (LIRs). Conduct independent investigations and respond to queries related to quality issues.
• Prepare weekly/fortnightly dashboards and monthly reports and keep track of audit observation trends, CAPAs, Deviations, LIR and other QA activities.
• Coordinate and support
• Review and assess work of direct reports and provide guidance preparation of external ISO audits (ISO/IEC 17025 and ISO 9001).
• Responsible to organize training to staff on ISO, Quality topics, QA department orientation and in-house procedures
• Responsible for goal setting, performance review and professional development of direct reports
• Adhere and promote USP core values within the department and throughout the organization.
• Master’s degree in Chemistry/Pharmacy/ Biotechnology/Bio-Chemistry with 12+ years of relevant experience in a pharmaceutical industry preferably in API or Finished Formulations, with 2-3 years of management experience in quality assurance.
• Strong working knowledge in Quality Assurance is highly preferred. Previous experience in analytical instrumentation, bioanalytical is preferred.
• Have thorough understanding on QA, GMP, GLP, and ISO regulations and the integration of the regulations into working systems in the Quality assurance.
• Excellent technical writing, English writing, 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 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.
• 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.
• Working knowledge of computer applications, such as MS Word and MS Excel and exposure to lab software such as e-LNB, NuGenesis, Empower and MetricStream, TrackWise would be advantageous.
Experience : 12+ years
Qualification : M.Sc, M.Pharm
Location : Hyderabad, AP
Industry Type : Pharma
Functional Area : Quality Assurance
Last date : 25th May, 2020
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