Executive/ Senior Executive – QC Analytical – at Enzene Bioscience, Apply Now!
Looking for a dynamic role in pharmaceutical quality control? Enzene Biosciences Ltd in Chakan, Maharashtra is hiring for the position of Executive/Senior Executive – QC Analytical. This opportunity is perfect for experienced professionals with expertise in analytical techniques, documentation, and regulatory compliance. If you excel in HPLC operations, LIMS, and method validation, apply now to contribute to a high-performing pharma QC team at a cutting-edge facility.
About Our Company
We are a leading pharmaceutical company located in Chakan, Maharashtra, India, dedicated to upholding the highest quality standards in the industry. Our team is committed to innovation, excellence, and ensuring the safety and efficacy of our products.
Position Overview:
We are seeking a dedicated and experienced Quality Control Analyst to join our pharmaceutical team. The ideal candidate will be responsible for ensuring the highest quality standards in our analytical processes, documentation, and laboratory operations.
Key Responsibilities:
Analyst Qualification & Training:
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Oversee the qualification process for analysts.
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Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices as QC Analytical.
Documentation Management:
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Prepare and review critical documents, including:
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Specifications
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Standard Testing Procedures (STPs)
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Technical Data Sheets (TDS)
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Standard Operating Procedures (SOPs)
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Certificates of Analysis (COA)
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Method Transfer Protocols (MTP)
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Method Validation Protocols (MVP) preferred for QC Analytical
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Method Validation Reports (MVR)
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Method Transfer Reports (MTR)
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Analytical Data Review:
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Review analytical data for routine samples, including:
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In-process samples
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Drug Substance (DS)
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Drug Product (DP) release for QC Analytical
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Stability samples
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Oversee method transfer and method validation processes.
Reference Standards & Material Management:
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Manage reference standards.
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Oversee the indenting process for materials required in QC.
Calibration Coordination:
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Coordinate with external vendors for instrument calibration.
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Collaborate with QC personnel for in-house calibration and verification of laboratory instruments preferred for QC Analytical.
Laboratory Equipment Maintenance:
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Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance as QC Analytical.
Method Validation & Transfer:
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Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results.
Quality Incident Management for Executive/ Senior Executive – QC Analytical:
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Initiate and investigate:
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Incidents
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Deviations
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Change controls
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Out of Specification (OOS) results
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Corrective and Preventive Actions (CAPA)
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Out of Trend (OOT) findings
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Analysis Planning:
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Plan and schedule analyses for:
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Drug Substance (DS)
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Drug Product (DP)
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Stability studies
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Protocol-based samples
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Qualifications for QC Analytical:
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Master’s degree in Chemistry or a relevant field.
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Minimum of [Insert Number] years of experience in a pharmaceutical quality control laboratory.
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Strong understanding of cGMP, GLP, and regulatory requirements.
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Excellent analytical and problem-solving skills.
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Effective communication and teamwork abilities.
Keywords: Executive QC Analytical, Quality Control Analyst, Pharmaceutical Team, Laboratory Operations, Documentation Management, Analytical Data Review, Calibration Coordination, Technical Expertise, Method Validation, Quality Incident Management
