: Senior Quality Assurance Specialist

Company: Hemshell Services (subsidiary of Hemetek Techno Instruments Pvt. Ltd.) Location: Vadodara (Baroda), Gujarat, India

Company Overview

Hemshell Services, established in 1995, is a NABL‑accredited ISO/IEC 17025:2017 laboratory specializing in pharmaceutical, packaging, polymer, food‑chemical, and microbiological testing.

The company also has a subsidiary in instrumentation manufacturing, expanding its footprint in calibration, testing, and training.

Position Summary The Senior QA Specialist will ensure compliance with GMP, GDP, ICH, ISO/IEC 17025, and 21 CFR Part 11/210/211 standards, manage audits, and strengthen quality systems across Hemshell’s pharmaceutical testing services. The role also extends to the instrumentation manufacturing subsidiary, where the candidate will establish and oversee a Quality Unit.

Key Responsibilities

- Quality System Oversight: Lead QA activities for stability, sterility, batch testing, and packaging evaluations.
- Audit Management: Prepare for, host, and respond to regulatory and client audits (FDA, EMA, WHO, NABL).
- Documentation Control: Approve SOPs, protocols, reports, and batch records ensuring 21 CFR Part 11 compliance for electronic records.
- Risk & Compliance: Implement CAPA, deviation handling, and change control systems aligned with 21 CFR Part 210/211.
- ISO/IEC 17025 Alignment: Ensure laboratory operations meet NABL accreditation requirements, including method validation, equipment calibration, staff competence, and impartiality.
- Subsidiary QA Leadership: Establish QA/QC processes for instrumentation manufacturing under Hemetek Techno Instruments.
- Training & Mentorship:



Conduct internal training on GDP, GMP, ISO 17025, and 21 CFR compliance.
- Cross‑functional Collaboration: Partner with R&D;, manufacturing, and client teams.
- Continuous Improvement: Drive initiatives to strengthen data integrity and compliance culture.

Qualifications

- Bachelor’s/Master’s in Pharmacy, Biotechnology, or Life Sciences.
- Minimum 6 years QA experience in the pharmaceutical industry.
- Proven track record of facing regulatory and client audits.
- Strong knowledge of GMP, GDP (ALCOA ), ICH guidelines, ISO/IEC 17025, and 21 CFR Part 11/210/211.
- Experience in third‑party testing labs or instrumentation QA preferred.
- Excellent communication, documentation, and leadership skills.

Soft Skills

- Leadership: Ability to inspire, mentor, and guide QA/QC teams.
- Problem‑solving: Analytical mindset to resolve deviations and audit findings effectively.
- Attention to Detail: Precision in documentation, compliance checks, and data integrity.
- Adaptability: Flexibility to manage QA across diverse domains (pharma testing instrumentation).
- Communication: Clear, concise, and persuasive communication with regulators, clients, and internal teams.
- Collaboration: Solid interpersonal skills to work cross‑functionally.
- Ethical Integrity: Commitment to transparency and compliance culture.

Growth Opportunity

This role offers progression into Head of Quality / Quality Unit Lead, harmonizing QA across both pharmaceutical testing and instrumentation manufacturing operations.

Pay: ₹1,000,000.00 - ₹1,500,000.00 per year

Benefits

- Cell phone reimbursement
- Paid sick time
- Paid time off
- Provident Fund

Work Location: In person

📌 Senior Quality Assurance Specialist (Makarpura)
🏢 TrialGuna
📍 Makarpura