Experience: Typically 8–15 years
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1. Job Purpose

The QC Manager is responsible for overseeing all quality control activities related to raw materials, in -process materials, and finished medical devices to ensure compliance with regulatory standards, GMP, and internal quality systems.

Key Responsibilities
Quality Control Operations

- Manage QC testing of raw materials, in -process samples, and finished products.
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- Ensure compliance with GMP, GLP, ISO standards, and regulatory guidelines.
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- Review and approve QC test results and batch release documentation.

- Maintain and improve laboratory systems and testing procedures.
Documentation & Compliance

- Ensure QC documentation, SOPs, and records are properly maintained and updated.

- Review and approve change control, deviation reports, and investigation reports.
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- Maintain laboratory compliance with regulatory audits and inspections.
Quality Systems

- Monitor calibration, validation, testing, and inspection activities.

- Ensure quality requirements are met during production and process control.

- Support CAPA (Corrective and Preventive Action) implementation.
Investigation & Troubleshooting

- Investigate OOS (Out of Specification) and OOT (Out of Trend) results.
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- Identify root causes and implement corrective actions.

- Ensure product quality is maintained throughout manufacturing.
Team Management

- Lead and supervise QC analysts and officers.

- Provide training on SOPs, testing methods, and compliance procedures.

- Coordinate with QA, Production, and Regulatory teams.
Key Skills

- Quality systems management

- Laboratory operations

- CAPA & deviation management

- Regulatory compliance

- Documentation & audit readiness

- Team leadership

Valuable laboratory practices, sample panel preparation, QC lab process set up, method validations, training, performance studies

RequirementsISO 13485, GLP, IVDR, WHO

Required Qualifications

- B. Sc / M. Sc / B. Pharm / M. Pharm or related science field

- 8–15 years experience in QC in pharma or medical devices
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- Knowledge of
- GMP / GLP

- ISO 13485

- Regulatory compliance (CDSCO / FDA / CE)

- Analytical instruments and lab systems
Please fill in the following Form
https://forms.zohopublic.in/merillifesciencespvtltd688/form/Quality Control Manager Candidate Application/formperma/zm_7oaQR_GN7VmlgGH4xsU1Tsi_cAOU -sI4NhYTkxn0

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📌 Senior Manager (India)
🏢 Meril
📍 India