Job Information
The U.S. Pharmacopeial Convention (USP) Quality Assurance Specialist in Hyderabad, India
Description
At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Brief Job Overview
QA Specialist is a hands-on, non-supervisory position that supports USP’s Quality Assurance team. The incumbent’s primary responsibility is the review of records for the qualification of reference standards. The position also supports the USP Internal Audit programs and the investigation of incidents and non-conformances. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent helps/co-lead to design, develop and implement new tools and techniques used in the overall Quality Systems at USP
How will YOU create impact here at USP?
Quality Systems :
-Support the development, implementation and monitoring of Quality programs, policies, and procedures to ensure compliance with certifications/accreditations requirements, corporate policies, and procedures.
-Support the Supplier Quality Management program by conducting supplier evaluations, audits, and supplier performance/metrics
-Review/approve the following:
Equipment IQ/OQ/PQ documents
Equipment calibration documents
Quality-related issues, complaints, deviations, and investigations with appropriate corrective/preventive actions.
Review/approval of technical and analytical documents of moderate to high complexity for Reference Standards and/or Analytical Reference Materials (ARM)
Method validation reports
Batch Records
Lab data projects
-Lead internal process/target audits according to a pre-defined schedule.
-Track and trend different elements of the quality system and report on the progress of the programs, including areas of strength and opportunities for improvement on a regular basis.
-Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies.
ISO 9001/17025: Participates in ISO 9001, ISO 17025, and other certification/accreditation activities.
-Performs other duties as required.
Who is USP Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
Master’s degree in science area (Chemistry, Pharmacy, Biology) and a combination of skills and experience in the pharmaceutical or related industry, preferably working in Development QA/Analytical Reviewer role/Quality Assurance in API or formulations.
A minimum of 8-10 years of experience in Quality, including developing and implementing a Quality Management System.
Minimum of three (3) years of hands-on experience in laboratory, handling of analytical equipment, qualification of analytical equipment, calibration, metrology and other laboratory activities is preffered.
Knowledge on Analytical Method validations related testing is an added advantage.
Must have successful experience with ISO 9001/17025 and/or GMP.
Strong written and verbal communication skills, including well-developed interpersonal skills used to influence the behavior of others and the ability to provide candid feedback at all levels.
Proficiency in conflict negotiation and resolution; ability to influence across disciplines and at all levels.
Ability to prioritize, manage time well, multitask and troubleshoot.
Working knowledge of MS Word, PowerPoint, Excel etc.,
Additional Desired Preferences
Strong leadership capabilities in a dynamic business environment.
Highly motivated, self-directed, and have the ability to work independently while handling multiple tasks.
Demonstrated ability to build strong, credible working relationships across the organization and to communicate and interface with customers, third parties, and diverse audiences at all levels of the organization.
Demonstrated ability to identify areas of potential quality non-conformance independently and successfully and to apply process acumen to resolve operational issues, identify gaps, reduce exposures, and assure conformance.
Ability to structure an issue and analyze alternative and creative solutions using metrics, good analytical skills, risk level, and other data and methods to evaluate data and trends for lessons learned, required action, etc.
Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
Proven ability to raise and resolve issues when others are directly accountable for outcomes.
Capability of uniting different elements to achieve a singular goal, creating strategies and policies, and altering company operations to succeed..
Supervisory Responsibilities
None
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific
Job Category Quality Assurance
Job Type Full-Time