Pharmaceutical QA

2 days ago

Ahmedabad Gujarat, India Swiftmed International Private Limited Full time

_**PLEASE READ BEFORE APPLYING* THIS IS NOT IT RELATED JOB**_

**Must Have Skills**:

- Pharmaceutical product Quality Control (RM, IPQC, Finished)
- Analytical skills (STP/MOA, AMV, PDR, etc)
- Pharma QA/QC Documents preparation
- Artwork/Packaging Review
- Workflow management
- Decision making
- Time management
- Proactive thinking

**Must have Sound Knowledge OR Experience**:

- Experience or Sound knowledge in Active Pharmaceutical Ingredients, Finish Product, Packaging Material Standards and Quality Management and Quality Control.
- Quality control tests applicable to all different formulations and API like Assay, Dissolution, Disintegration, Uniformity of Weight/dosage, Impurity testing, Water content, etc and applicable methods like HPLC, GC, TLC, IR/UV, Disso, etc
- Interpreting results of HPLC and understanding chromatograms
- Knowledge about all documentation applicable in QA/QC
- Experience preparing BMR, SPEC, STP, AMV/PDR Protocol, Report, Validation of Equipment, Critical Control Steps and various other documents.
- Plant audit/inspection knowledge/experience is an asset.
- Prepare/review documents, templates, SOPs related to QA/QC
- Prepare/Verify AMV, STP, and other documents for the product
- Ensuring highest quality for API are planned & used in Manufacturing Finished Products.
- Ensuring highest quality and design for Packaging are sourced, planned & used in Packaging of Finished Products.
- Coordinate & Ensure Finished products are tested as per requirements prior to product dispatch including performing visual inspection as well as coordinating with third party labs to check finished pharmaceutical products to ensure they meet predefined specifications.
- Coordinate with Quality Control (QC) teams of plant to ensure the accuracy of testing procedures and results.
- Investigate deviations and propose corrective and preventive actions (CAPA).
- Specifically preparing & reviewing Master Formula Records (MFR), Q&Q (Quality & Quantity) documents, Standard Test Procedures (STP), Stability protocols & reports, Analytical Method Validation (AMV), Process Validation Protocols (PVP), and Product Development Reports (PDR) and any other document relating to Product Quality.
- Maintain accurate and up-to-date documentation in accordance with Good Documentation Practices (GDP).
- **Manufacturing Facility Inspection**: Conduct inspections of the manufacturing facility to ensure compliance with cGMP, and other regulatory guidelines. Identify and address compliance gaps in manufacturing processes. Work closely with production and quality teams to improve process efficiencies and compliance.

Pay: From ₹30,000.00 per month

**Benefits**:

- Flexible schedule
- Paid sick time

**Education**:

- Diploma (required)

**Experience**:

- Pharmaceutical: 1 year (required)

**Location**:

- Ahmedabad, Gujarat (preferred)

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