Senior Quality Assurance Specialist
Location
Secunderabad | India
Job description
POSITION TITLE: Senior Quality Assurance Specialist
DEPARTMENT: Quality Assurance
LOCATION : Hyderabad
Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor ______________________________________________________________________________
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.
The Role: Our Sr. Quality Assurance Specialist will provide daily oversight of Ora's quality management system and notifies applicable supervision/management of unauthorized deviations. This role will ensure that employees adhere with all standard operating procedures, as applicable to their individual roles. In addition, they will actively participate in establishing quality goals and objectives and provide related input to business development and strategic planning, as required. They will conduct detailed inquiries into quality related issues to develop lessons learned and analyze related metrics for trends and improvement opportunities.
In partnership with our Operations Team, they will support projects by performing required audits, identifying related risks, and ensuring compliance to internal policies and procedures and external regulatory requirements. They will develop, maintain, and communicate detailed project plans to stakeholders and identify potential impacts to project timelines proactively and work with necessary cross functional team(s) as appropriate to develop resolution plans and implement accordingly.
What You'll Do: - Work with our Operations Team to support projects by performing required Trial Master File (TMF) audits, identifying related risks and ensuring compliance to internal policies and procedures and external regulatory requirements.
- Identify potential impacts to project timelines proactively as a result of TMF audits and review and work with necessary cross functional team(s) as appropriate to develop resolution plans and implement accordingly.
- Investigate and respond to Corrective and Preventive Action (CAPA) and work with Operations to obtain evidence of deliverables and facilitate effectiveness checks as needed to ensure CAPA closure.
- Assist in the preparation, execution, as well as the drafting and tracking of responses to external audits and inspections.
- Identify areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate QA staff.
- Creation and tracking of lessons learned activities from TMF audits.
- Assists in creation, tracking, and reporting of QA metrics and KPIs.
- Assists in development and modification of departmental work instructions and collaborates with appropriate CQA staff to ensure alignment with SOPs.
- Work collaboratively with our Operations Team to ensure departmental policies and procedures are kept current.
- Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation.
- Participate in development of electronic tracking / filing systems in support of quality throughout TMF maintenance process.
- Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.
- Provide quality management system support during client and supplier meetings as needed.
- Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirements.
- Clear and sustained demonstration of the Ora Clinical Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
What We Look For: - Experience needed for the Role:
- Bachelor's Degree in Applied Life Science or Engineering.
- 5+ years of experience in quality assurance.
- General aptitude in the art and science of quality assurance procedures and methods.
- Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.
- Experience in clinical research within a CRO environment is preferred.
- Additional Skills and Attributes:
- Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
- Knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
- Excellent verbal and written communication skills.
- Competencies and Personal Traits:
- Attention to Detail: Ability to analyze data to drive successful solutions to complex problems.
- Emotionally Intelligent Leadership: Ability to lead with a positive mindset and empathy.
- Intellectual Curiosity: Willingness and desire to learn new things and dig deeper than the surface.
- Innovative Mindset: Forward thinking, creative and open to testing, making mistakes and trying again.
- Organization and Goal Setting: Ability to set goals, develop structure and maintain a focused approach to critical path work.
- Resolve Conflicts: Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
- Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world.
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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