Overview
Senior Quality Assurance Specialist Jobs in Hyderabad, Telangana, India at Synapmed
Title: Senior Quality Assurance Specialist
Company: Synapmed
Location: Hyderabad, Telangana, India
Job Description (JD) – Senior Quality Assurance Specialist
Position: Senior Quality Assurance Specialist
Department: Quality Assurance
Location: Hybrid- Hyderabad
Experience: 5–6 Years
Position Summary
We are seeking an experienced and detail-oriented Senior Quality Assurance Specialist to support and manage the organization's Quality Management System (QMS), Computer System Validation (CSV) activities, ISO compliance programs, and regulatory audit readiness. The ideal candidate should possess strong experience in Pharmacovigilance quality systems, regulatory compliance, audit management, and quality oversight activities within a healthcare, life sciences, or pharmacovigilance environment.
Key Responsibilities
Quality Management System (QMS)
- Manage and maintain the organization's Quality Management System in compliance with applicable regulations and standards.
- Develop, review, approve, and maintain quality documents including:
- SOPs
- Policies
- Work Instructions
- Forms and Templates
- Quality Manuals
- Ensure effective document control and periodic review processes.
- Manage deviations, CAPAs, change controls, non-conformances, and quality events.
- Monitor quality metrics and prepare periodic quality reports for management review.
- Support continuous improvement initiatives across business functions.
ISO 9001:2015 Compliance
- Maintain and continuously improve the ISO 9001:2015 Quality Management System.
- Plan, conduct, and manage internal audits.
- Coordinate external certification, surveillance, and recertification audits.
- Ensure closure of audit observations through effective CAPA management.
- Support Management Review Meetings (MRM) and quality objectives monitoring.
Audit & Regulatory Compliance
- Lead and coordinate customer, vendor, certification, and regulatory audits.
- Act as the primary Quality representative during client and regulatory inspections.
- Prepare audit plans, responses, and compliance documentation.
- Track audit findings and ensure timely implementation of corrective and preventive actions.
- Perform vendor qualification and periodic vendor audits.
- Support compliance with applicable GxP, Pharmacovigilance, and healthcare regulations.
Computer System Validation (CSV)
- Support and lead CSV activities for validated systems.
- Review and approve validation documentation including:
- Validation Plans
- User Requirement Specifications (URS)
- Functional Specifications (FS)
- Risk Assessments
- IQ/OQ/PQ Protocols
- Validation Reports
- Participate in change control assessments related to validated systems.
- Ensure compliance with GAMP 5 principles, 21 CFR Part 11, and applicable computerized system requirements.
- Support periodic review and validation lifecycle activities.
Pharmacovigilance Quality Assurance
- Conduct Pharmacovigilance Quality Reviews and compliance assessments.
- Support PV audits, inspections, and quality oversight activities.
- Review PV agreements, quality agreements, and compliance documentation.
- Monitor implementation of PV-related CAPAs and quality actions.
- Ensure compliance with global PV regulations and client requirements.
Training & Compliance
- Manage quality and compliance training programs.
- Conduct employee training on QMS, ISO, CSV, and regulatory requirements.
- Monitor training effectiveness and compliance status.
- Support onboarding quality training programs.
Qualifications
Education
- Bachelor's or Master's degree in:
- Pharmacy
- Life Sciences
Experience
- 5–6 years of experience in Quality Assurance within Pharmacovigilance, Healthcare, CRO, Life Sciences, or related industries.
- Hands-on experience with ISO 9001:2015 Quality Management Systems.
- Experience managing regulatory, client, and certification audits.
- Experience in Computer System Validation (CSV) activities.
- Exposure to Pharmacovigilance Quality Assurance processes.
- Experience with CAPA, deviations, change controls, and document management systems.
Required Skills
- Strong knowledge of ISO 9001:2015 requirements.
- Knowledge of GxP, GVP, and regulatory compliance requirements.
- Understanding of GAMP 5 and CSV principles.
- Strong auditing and root cause analysis skills.
- Excellent documentation and technical writing abilities.
- Strong stakeholder management and client-facing skills.
- Ability to work independently and manage multiple priorities.
- Excellent communication and presentation skills.
Preferred Qualifications
- Certified Internal Auditor (ISO 9001:2015).
- ASQ Quality certifications or equivalent.
- Computer System Validation (CSV) certification.
- Experience supporting global clients and regulatory inspections.
- Experience with electronic QMS platforms and validated systems.
Key Competencies
- Quality & Compliance Mindset
- Leadership & Ownership
- Attention to Detail
- Risk-Based Decision Making
- Continuous Improvement
- Client Focus
- Problem Solving & Root Cause Analysis
- Effective Communication
Reporting To: Head – Quality Assurance & Compliance
This role offers an excellent opportunity to contribute to Synapmed's quality and compliance excellence while supporting global healthcare and pharmacovigilance operations.
