Job Title: Quality Assurance Analyst
Location: Bangalore, Karnataka
Function: Quality Assurance
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by
Reviewing, approving and analyzing both internal and external compliance related issues and reports, corrective and preventive actions (CAPA), deviations and notes to file (NTF).
Ensuring all compliance issues are tracked and trended as well as closed in a timely manner
Performing all functions of both internal and external quality assurance (QA) audits including audit initiation, conducting the audit, issuing an audit report with pertinent observations/findings, and ensuring corrective and preventive actions resulting from the internal audit are appropriately tracked/trended and resolved accordingly
Performing a Quality Assurance review of Software Development Lifecycle (SDLC) validation packages
Supporting Computer System Validation (CSV) program
Tracking and reporting data errors detected during review processes
Communicating effectively, verbally and in writing, with all internal and external clients
Escalating quality concerns and problems to the Manager QA or designee(s)
Designs, develops, implements, and assists in management of all quality assurance programs by assisting the Manager, QA with identifying and implementing process enhancements to Sitero's quality systems and processes through appropriate stakeholders
Supporting external (vendor/supplier) quality audits and hosts Sponsor audits as needed
Facilitate quality training of peers on quality related matters as needed
Management and implementation of ISO, SOC and other certification requirements as required
Maintains Quality Service and Departmental Standards by
Reading, understanding and adhering to organizational Standard Operating Procedures (SOP)
Assisting in establishing and enforcing departmental standards
Developing or revising SOPs
Contributes to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by
Attending and participating in applicable company-sponsored training
Attending educational workshops and reviewing professional publications
Keeping informed of changes in the regulatory environment and/or regulatory requirements
EDUCATION AND EXPERIENCE REQUIRED:
Education:
Bachelor's degree in science or related field required
Quality Auditor certification, or equivalent, is preferred
Experience:
3+ years relevant experience in areas of Quality Assurance, Auditing, Validation and/or SDLC systems in regulated industries
3+ years relevant experience in areas of Software Development Life Cycle systems, Information Technology /Cloud in regulated industries.
Possesses a strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, Software Validation requirements, ISO and is competent with Quality Management Systems (QMS).
Knowledgeable of 21 CFR Part 11, Annex 11 and other applicable ERES regulations
Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
Understanding of medical and/or clinical trial terminology is desirable
PREFERRED SKILLS:
Ability to work in group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Full Time, Contract
COMMITMENTS:
Standard Hours 40 hours per week, one hour lunch, Monday Friday. Additional hours as needed.
Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
