Associate Manager – Quality Systems (Biologics Manufacturing)

HypTechie; India; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

HypTechie is seeking an experienced Associate Manager – Quality Systems to oversee global quality standards in biologics manufacturing. The role focuses on data integrity, GDP/GMP compliance, and documentation oversight.

You will review analytical data, drive investigations of deviations and incidents, and support regulatory adherence across manufacturing sites. Ideal candidates have 5–8 years in Quality Assurance within regulated biologics/pharma environments and hold an M.Sc.

Qualifications

• M.Sc. in Life Sciences, Biotechnology, Chemistry or related field.
• 5–8 years of QA / Quality Systems experience in regulated biologics or pharma manufacturing.
• Strong background in cGMP, GDP and data integrity.

Responsibilities

• Establish and maintain global quality system standards for biologics manufacturing.
• Ensure GDP-compliant documentation during review, approval and closure of records.
• Review batch analytical data for accuracy, completeness and authenticity.
• Analyze trends in environmental monitoring, water testing, stability studies, and lab incidents.
• Participate in investigations of OOS, OOT, OOL deviations and incidents.

Skills

Quality Systems

Data Integrity

cGMP

GDP

Documentation Practices

Education

M.Sc. in Life Sciences / Biotechnology / Chemistry

Job description

Location: [Insert Location]

Experience: 5 – 8 Years

Education: M.Sc. (Life Sciences / Biotechnology / Chemistry or related discipline)

Role Summary

We are seeking an experienced Associate Manager – Quality Systems to oversee global quality standards in biologics manufacturing. The role involves ensuring data integrity, documentation compliance, quality investigations, environmental monitoring, and supporting regulatory adherence. The ideal candidate should have a strong background in cGMP, GDP, and quality systems with hands‑on experience in reviewing analytical data, managing incidents, and driving quality excellence.

Key Responsibilities

• 1. Quality System Oversight : Establish and maintain global quality system standards for biologics manufacturing.
• 2. Documentation Practices : Ensure adherence to Good Documentation Practices (GDP) during review, approval, and closure of records.
• 3. Data Review & Integrity : Review batch analytical data for accuracy, completeness, and authenticity.
• Environmental Monitoring & Testing : Analyze trends in environmental monitoring, water testing, stability studies, and laboratory incidents.
• 5. Investigations & Incident Management : Participate in investigations of OOS (Out of Specification), OOT (Out of Trend), OOL (Out of Limit), deviations, and incidents.

Educational Qualifications & Experience

• Education: M.Sc. in Life Sciences / Biotechnology / Chemistry (or related field).
• Experience: 5 – 8 years in Quality Assurance / Quality Systems within a regulated biologics or pharmaceutical manufacturing environment.