Executive/ Senior Executive

1 week ago

Mumbai, Maharashtra, India Enzene Biosciences Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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:

  1. Analyst Qualification & Training:
  • Oversee the qualification process for analysts.
  • Conduct and coordinate training programs for QC employees to ensure compliance with current standards and practices.
  1. Documentation Management:
  • Prepare and review critical documents, including Specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Transfer Protocols (MTP), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR).
  1. Analytical Data Review:
  • Review analytical data for routine samples, including in-process samples, Drug Substance (DS), Drug Product (DP) release, and stability samples.
  • Oversee method transfer and method validation processes.
  1. Reference Standards & Material Management:
  • Manage reference standards and oversee the indenting process for materials required in QC.
  1. Calibration Coordination:
  • Coordinate with external vendors for instrument calibration.
  • Collaborate with QC personnel for in-house calibration and verification of laboratory instruments.
  1. Laboratory Equipment Maintenance:
  • Ensure proper maintenance and management of laboratory equipment and instruments to guarantee optimal performance.
  1. Method Validation & Transfer:
  • Manage activities related to method validation and method transfer to ensure accurate and reliable analytical results.
  1. Quality Incident Management:
  • Initiate and investigate incidents, deviations, change controls, Out of Specification (OOS) results, Corrective and Preventive Actions (CAPA), and Out of Trend (OOT) findings.
  1. Analysis Planning:
  • Plan and schedule analyses for Drug Substance (DS), Drug Product (DP), stability studies, and protocol-based samples.

Technical Expertise:

  • Proficient in handling High-Performance Liquid Chromatography (HPLC) instruments, including Reverse Phase HPLC (RP-HPLC).
  • Experience with Laboratory Information Management Systems (LIMS).
  • Skilled in using chromatography data systems such as Chromeleon and Empower 3.
  • Familiarity with Cation Exchange Chromatography (CEX) techniques.

Qualifications:

  • Master's degree in Chemistry or a relevant field.
  • Minimum of 4 - 8 years of experience in a pharmaceutical quality control laboratory.
  • Strong understanding of cGMP, GLP, and regulatory requirements.
  • Excellent analytical and problem-solving skills.
  • Effective communication and teamwork abilities.

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