Quality Assurance Manager

GPT Freelancer

8 - 10 Years
1 Openings
6.0-7.5 Lac/Yr
Indore
Posted 24 days ago
Face-to-Face interview

Key Skills

GLP GMP Documentation CAPA Ipqc SOP Preparation Cgmp Internal Audit Quality Assurance QA-quality Assurance Quality Control Quality Analysis QC Inspection Quality Check

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Job Description

QA Manager / Asst QA Manager Responsibilities:-

To handle calibration & validation activities at site.

Preparation & review of Technical Documents like Site Master File, Validation Master Plan, Qualifications & Validation Protocols, Validation Reports, Master Formulas, Batch Manufacturing & Packing Records, Policies, Manuals Work Instructions, general and standard specifications and testing procedures & Standard Operating Procedures.

To prepare, review & report annual product reviews & product stability reports.

To investigate complaints, deviations, quality incidents and non-conformances and ensure implementation of CAPA.

To control IPQC activities in production and packing of finished products.

To handled external audits like regulatory audits and vendor audits.

To indent QA requirements.

To approve (sanction) leaves of QA department personnel..

To conduct internal audits as per current Good Manufacturing Practices (cGMP) requirements.

To issue Corrective Action & Preventive Action and to do follow up for effective implementation of Corrective Action & Preventive Action.

To review and approve out of specification, quality incident, deviation, change control, validation documents.

To Review and Release manufactured batch.

Revision of SOPs & it's integration with Corporate Documents.

Act as the pollution prevention, waste minimization and energy team member where applicable.

Implementation of Quality Management System & Environment Management System requirements as applicable to IPQC function.

To conduct training on Good Manufacturing Practices/Good Laboratory Practices in coordination with Human Resources department.

Vendor development, evaluation & assessment of suppliers through audits

To review Batch Manufacturing Records.

To perform gap & risk analysis.

To handle change controls.