Pharma quality incharge (indore)
Pharma quality incharge (indore)
Posted on :
09-08-2025
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1 Vacancy
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Job Description
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pharmaceutical Quality Control (QC) professional ensures that drugs and related products meet quality standards throughout their lifecycle from raw materials to finished goods. This involves a range of activities including testing analysis and documentation all while adhering to regulatory guidelines and company procedures.
Key Responsibilities:
Testing and Analysis:
Conducting various tests on raw materials in-process samples and finished products using analytical techniques like HPLC GC UV and spectroscopy.
Quality Standards Compliance:
Ensuring products meet established quality standards specifications and regulatory requirements (e.g. GMP ICH USFDA WHO).
Documentation and Reporting:
Maintaining detailed records of all testing analysis and investigations including preparing certificates of analysis and other relevant reports.
Equipment Management:
Calibrating maintaining and troubleshooting analytical instruments and equipment.
Deviation Investigations:
Investigating and documenting any deviations from established quality standards or procedures (e.g. Out of Specification (OOS) results) and implementing corrective and preventive actions (CAPA).
Stability Studies:
Conducting and documenting stability studies to assess product shelf life and storage conditions.
Method Validation:
Validating analytical methods to ensure they are suitable for their intended use.
Training and Supervision:
Training and supervising QC technicians ensuring they adhere to quality standards and procedures.
Audits and Inspections:
Participating in internal and external audits and inspections addressing any findings and ensuring compliance.
Inventory Management:
Managing the inventory of reagents standards and other materials needed for QC analysis.
Process Improvement:
Identifying opportunities to improve the efficiency and effectiveness of QC processes.
Skills and Qualifications:
Education:
Typically requires a Bachelors or Masters degree in Chemistry Biochemistry Microbiology or a related field.
Analytical Skills:
Strong analytical and problem-solving skills including the ability to interpret data troubleshoot issues and make informed decisions.
Technical Skills:
Hands-on experience with relevant analytical techniques and instrumentation.
Regulatory Knowledge:
Understanding of cGMP ICH guidelines and other relevant regulatory requirements.
Attention to Detail:
Meticulous attention to detail is crucial for accurate testing documentation and investigations.
Communication and Interpersonal Skills:
Ability to effectively communicate with team members management and other stakeholders.
Problem-solving skills:
Ability to identify the root cause of quality issues and implement effective corrective actions.
Employment Type
Full Time
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