Assistant General Manager, Quality Assurance
ConfidentialAhmedabad, India4 days ago
Job descriptionTo perform other activities assigned by HOD Bachelors Degree (BA / BS) B. Pharma - Required Master Degree (MS / MA) M. Sc - Required Master Degree (MS / MA) M. Pharma - Preferred 12 years or more in 12 - 15 Years Regulatory Compliance & Validation Guidelines (FDA, EMA, ICH, WHO) - Advanced Validation Master Plan (VMP) Development & Execution - Advanced Process Validation (PV) for Oncological Injectables - Advanced Cleaning Validation (CIP / SIP) & Residue Limit Justification - Advanced Aseptic Process Validation (Media Fill Studies) - Advanced Sterilization Validation - Advanced Equipment Qualification (DQ, IQ, OQ, PQ) - Mastery Environmental Monitoring & HVAC Qualification - Advanced Deviation Handling, CAPA & Change Control in Validation - Mastery Analytical Quality Assurance - Advanced Equipment & Facility knowledge - Advanced Investigation - Mastery
Essential Functions
JOB DESCRIPTION
- Responsible for cGMP compliance review in QC laboratory
- Responsible tenure the completeness of the analytical documents and approval of CoA of Raw materials, packaging materials, In-process, finished products, stability study intended for submission, validation & commercial batches.
- Responsible to perform / review of the investigation for Quality issues like OOS, Deviations, Incidents, CSIR of QC laboratory
- Responsible to ensure the implementation of CAPAs recommended in OOS, OOAL, Incidents and deviations related laboratory.
- Responsible for the review of Change controls related to QC laboratory.
- Responsible for the review of chromatographic and non-chromatographic data in Empower / LIMS and its audit trail tenure the data integrity.
- Responsible for the review and approve of LIMS audit trail for Plant Locations tenure the data integrity.
- Participates in the development and implementation of SOPs for laboratory compliance or relevant QC functions.
- To ensure the adequacy of Standardization / Characterization data of working / Impurity standards in QC.
- To review and approve Quality control documents like qualification documents / Calibration report of instruments.
- Responsible to impart trainings the subordinates and other personnel for development.
- Responsible for review and approve of Raw material sample quantity evaluation form cum list and raw material storage condition for the materials applicable for Plant Locations.
- Responsible for review and approve of reduce and enhance reduce testing report of raw materials and packaging materials.
- Responsible for review of Elemental impurity and Nitrosamine impurity risk assessment report of the products applicable for plant locations.
- Responsible for management of manufacturer address of materials in BLPS software and approval of GRN in BLPS software.
- Responsible to review and approval of stability protocol in LIMS, Miscellaneous study protocols & related reports in laboratory.
Additional Responsibilities :
Education
QUALIFICATIONS
Experience
Skills
Specialized Knowledge : Licenses :
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Skills Required
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Quality Assurance Manager • Ahmedabad, India