MARIMUTHU P
IPQA & Quality compliance
Hosur
Summary
Driven by a commitment to professional excellence and a passion for contributing to organizational growth ,actively seeking executive level or team leadership in assignment in Quality Assurance - IPQA.As a seasoned senior executive bring a wealth of expirence,particularly in injectable formulation (Soft floor) and have accumulated over 6.9 years of expertise in IPQA and compliance.
Overview
7
7
years of professional experience
17
17
years of post-secondary education
Work History
Assistant manager in Quality compliance
Maiva pharma Pvt Ltd
05.2024 - Current
- To monitor the aseptic manufacturing practices and Good manufacturing processes (GMP) being followed in the shop floor on regular basis.
- To walk-through in aseptic and non-aseptic area as part of Quality compliance.
- To escalate unacceptable aseptic manufacturing practices is being followed in the shop floor to production supervisors and head and for corrective action.
- To co-ordinate with the production supervisors and head to implement corrective actions.
- To verify the effectiveness of corrective action is being implemented.
- To monitor interventions simulated in the media-fill study versus on-going routine and non-routine interventions facing on daily manufacturing process.
- To escalate the Quality Control Microbiology, Production, QA supervisors and Heads, if any mismatch in the simulation study.
- To monitor aseptic manufacturing practices being followed by the personnel in shopfloor online on spot and through CCTV online.
- To walk through with-in the manufacturing facility to ensure the compliance, if any gaps identified escalate to production supervisor/head and Quality Head.
- Co-ordinate with CFT and ensure implementation of committed CAPA.
- To arrange periodic meeting with CFTs.
- To provide training to the personnel on SOP and Practices as on when required.
- To verify audit trial report of manufacturing equipment and instrument and escalate to user department head, QA Head if any non-conformance observed.
- To prepare and review of SOP, protocol, report and other general GMP document w.r.t Quality Compliance.
- To initiate and review of change control.
- To log the deviation and to participate in investigation process if required.
- To perform unscheduled audit across the department and initiate QMS event if required.
- Audit exposure: USFDA, MHRA, EU, Customer audit
Trainee executive to senior executive in IPQA
Maiva pharma Pvt Ltd
09.2018 - 04.2024
- Raw Material Dispensing: Monitoring and line clearance for dispensing of raw material and review of equipment's calibration status.
- Production Activities: Line Clearance and monitoring of related activities.
- Decartoning of Ampoules and Vials.
- Washing Machine / Room and sterilization / De-pyrogenation of tunnels.
- Manufacturing activities: To ensure the equipment under calibration and validation, which used for manufacturing activities.
- Filling activities in process checks for (Weight variation, Volume variation, clarity checks, particulate matter, cosmetic defects etc.,).
- Coordination and collection of Process Validation Samples, Hold Time Samples, regular batch samples and Cleaning Validation Samples as per sampling plan.
- Verification and review of filter Integrity apparatus and bubble point apparatus, Process related Log Books / Sterilization Graph routine review.
- Review of meta data for the online NVPC and offline NVPC monitoring, Glove Port Glove Integrity and Filter Integrity tests.
- Supporting to validation team during validation activity.
- Review of Cleaning & Disinfection of Aseptic and Non-aseptic area.
- Review of Batch Manufacturing Record and Batch Packing Record.
- In process Challenge studies.
- Audit trail review of production equipment's.
- Inspection: Inspection activities line clearance.
- AQL (Acceptance Quality Limit) Check.
- Identification of rejects and intimate to the immediate supervisors.
- To ensure the equipment's under calibration and validation, which used for inspection activities.
- Involved the Qualification of visual inspection kit.
- Packing & Finished Goods: Packing activity clearance for ampoule and vials.
- In Process challenge studies (Camera Studies).
- To ensure the equipment's under calibration and validation, which used for packing activities.
- Coordination and line clearance for finished goods dispatch and temperature monitoring for the particular products.
- Monitoring of Cold Chain Products and verification of finished products stock in Quarantine and cold room against the stock Log Book / Stock List.
Education
Master of Science - Microbiology
Periyar University
Krishnagiri, India 04.2001 - 01.2018
Skills
Operations management
IT FORTE
- Well versed in MS office
- Excel
- Windows
- Internet application
- Sound knowledge in ERP application
Timeline
Assistant manager in Quality compliance
Maiva pharma Pvt Ltd
05.2024 - Current
Trainee executive to senior executive in IPQA
Maiva pharma Pvt Ltd
09.2018 - 04.2024
Master of Science - Microbiology
Periyar University
04.2001 - 01.2018
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