Quality Assurance (QA) and Quality Control (QC) departments are essential in the pharmaceutical industry to ensure the safety, efficacy, and quality of products. Here's an overview of their roles:
Quality Assurance (QA)
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Definition:
- QA focuses on ensuring that all processes involved in the production of pharmaceutical products meet regulatory requirements and quality standards.
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Key Responsibilities:
- Developing and implementing Standard Operating Procedures (SOPs).
- Overseeing Good Manufacturing Practices (GMP) compliance.
- Ensuring documentation accuracy and completeness.
- Conducting internal and external audits.
- Reviewing and approving batch records.
- Implementing quality risk management.
- Investigating deviations, complaints, and implementing corrective and preventive actions (CAPA).
- Training staff on quality procedures.
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Goal:
- Prevent errors during production rather than detecting them after they occur.
Quality Control (QC)
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Definition:
- QC focuses on testing and verifying that raw materials, in-process samples, and finished products meet the required specifications.
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Key Responsibilities:
- Testing raw materials, intermediates, and finished products.
- Conducting stability testing to assess product shelf life.
- Performing analytical method validation.
- Operating and maintaining laboratory equipment.
- Preparing and standardizing reagents.
- Ensuring compliance with pharmacopeial standards (e.g., USP, EP, JP).
- Investigating out-of-specification (OOS) results.
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Goal:
- Detect defects or issues in products to ensure only compliant products are released.
Collaboration Between QA and QC
- QA and QC are complementary: QA establishes the systems and standards, while QC ensures the standards are met through testing.
- Both departments collaborate on:
- Investigating and resolving product issues.
- Ensuring regulatory compliance during inspections.
- Implementing process improvements.
Regulatory Importance
- Both departments are crucial for compliance with global regulatory agencies like:
- FDA (Food and Drug Administration).
- EMA (European Medicines Agency).
- MHRA (Medicines and Healthcare products Regulatory Agency).
- WHO (World Health Organization).
- Non-compliance can lead to product recalls, regulatory penalties, or facility shutdowns.
We are hiring freshers for QA/QC Department.
Qualification - B.Sc &M.Sc Life Sciences
Salary-As per company norms
Preferably Immediate joiners only.
*Rotational Shift Applicable
Interested candidates can share their Updated resume to *sandhya5318@bharatbiotech.com".
Kindly mention "Applying for Quality Department" in Subject line.
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