Meril
Website:
merillife.com
Job details:
Experience: Typically 8–15 years
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.
- Ensure compliance with GMP, GLP, ISO standards, and regulatory guidelines.
- 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.
- 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.
- 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
Good laboratory practices, sample panel preparation, QC lab process set up, method validations, training, performance studies
Requirements
ISO 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
- 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/QualityControlManagerCandidateApplication/formperma/zm_7oaQR_GN7VmlgGH4xsU1Tsi_cAOU-sI4NhYTkxn0
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