Sr. Executive QC/QA - BIORAD MEDISYS PVT.LTD
(2023-10)
Biorad Medisys is one of the leading manufacturers & Exporter of Quality medical device products in the field of Urology, Gastrology & Gynecology.
- Responsible for conducting Internal Quality Audit (IQA), Management Review Meeting (MRM) & maintenance & handling - ISO 9001, ISO 13485 documents.
- Handling of Change control & CAPA documents.
- Conducting & document internal audits and other quality assurance activities.
- Coordinate and support on-site audits conducted by external providers.
- Evaluate audit findings and implement appropriate corrective actions.
- Investigate customer complaints and non-conformance issues
- Handling of QMS events i.e. Deviations, Investigations, Market complaints, Risk assessments, CAPA, Change control,.
- Preparation of Technical File & Stability study reports for Urology Products
Senior Microbiologist - SHIVA ANALYTICALS INDIA PVT.LTD
It is the foremost analytical testing labs in india. it provides analytical services in Pharmaceuticals, food & beverages, ores and minerals.
- Performing of bio burden testing and sterility testing of medical devices.
- Monitor all reports of noncompliance resulting from customer and regulatory audits to ensure corrective action plans are in place.
- Qualification and validation of Eqipments.
- Performed MLT test of raw material testing of drug products.
- Sterility test method validation for Latex surgical gloves.
- Performed disinfectant efficacy test of IPA and Sanitizers
- Conducting Internal Audits according to ISO/IEC 17025:2017
- Performed Filter integrity test of ophthalmic vials.
- Conducting training programs to junior microbiologists.
- Validation and calibration of Equipment's and Instruments
- Certified Internal Auditor of ISO/IEC 17025:2017 from the company
QA Executive - Himalaya Drug Company
It produces health care products under the name Himalaya Herbal Healthcare whose products include Pharma products.
- Conducting internal audits and preparing audit documents.
- Document and reporting quality and compliance issues to QA management.
- Assist in preparation and review of corrective action plans.
- Conducting training on GDP, GLP and GMP guidelines.
- Reviewing analytical method protocols and sending data discrepancies.
- Reviewing of Raw material and Finished product documents.
- Conducting training on regular updating of guidelines to QC department.
- Preparation of Corrective and preventive action reports.
- Handling of OOS and Deviations and preparing investigation reports
QC Officer - Healthium Medtech Ltd
Manufacturer and Exporter of all varieties of Absorbable and Non-absorbable surgical sutures, Hernia mesh, Bone wax, Surgical gloves and surgical tapes.
- Verification of Eto sterilization process and sterility reports
- Batch record review and batch line clearance in production areas
- Biological indicator (Bacillus atropheus) testing of sutures.
- Maintenance of microbial cultures.
- Bioburden testing & Sterility testing of Polyproylene mesh, polythene sutures, silk, Hand gloves etc.
- Batch record reviewing & reconciliation.
- QA Documentation and Raising CAPA and review.
QC Officer - MICROLABS
It is the leading drug manufacturing company in production of Parental, capsules and tablets.
- Microbial limit test and Sterility test of Finished Product and Raw Materials.
- QC Documentation
- Media preparation and maintaining media stock.
- Autoclave validation.
