Senior Manager (Killa-pardi)

Senior Manager (Killa-pardi)

01 Aug
|
Recognized
|
Killa-pardi

01 Aug

Recognized

Killa-pardi

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






Positive 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



📌 Senior Manager (Killa-pardi)
🏢 Recognized
📍 Killa-pardi

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