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Job Location drjobs

Tamil Nadu - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title: Quality Control Executive
Department: Quality Control

Job Summary:
We are seeking a highly skilled and detailoriented Quality Control Executive to join our team in the pharmaceutical API industry. The ideal candidate will be responsible for ensuring the quality and compliance of active pharmaceutical ingredients (APIs) throughout the manufacturing process. This role requires expertise in quality control testing regulatory standards and a strong commitment to maintaining high product quality.

Key Responsibilities:
  • Conduct quality control testing of raw materials inprocess materials and finished products in accordance with established procedures and standards.
  • Perform advanced analytical techniques such as HPLC GC UVVIS and titrations for routine and nonroutine analysis.
  • Ensure compliance with cGMP (current Good Manufacturing Practice) GLP (Good Laboratory Practice) and other regulatory requirements.
  • Review and interpret analytical data perform troubleshooting and assist in investigations of deviations or outofspec results.
  • Maintain and calibrate laboratory equipment ensuring they are in proper working condition and compliant with regulatory standards.
  • Support the validation and qualification of analytical methods and laboratory instruments.
  • Prepare and review stability studies methods specifications and related documents.
  • Ensure thorough documentation of all testing analysis and laboratory activities maintaining compliance with GMP guidelines.
  • Participate in internal and external audits inspections and quality control reviews.
  • Collaborate with crossfunctional teams (Production R&D Regulatory Affairs) to resolve qualityrelated issues and drive continuous improvement.
  • Oversee the safe handling and storage of reagents chemicals and controlled substances per safety regulations.

Qualifications:
  • Bachelor s degree in Pharmaceutical Sciences Chemistry or a related field.
  • 47 years of experience in Quality Control within the pharmaceutical or API industry.
  • Advanced knowledge of analytical techniques laboratory instrumentation and quality control methodologies.
  • Solid understanding of GMP GLP ICH guidelines and other regulatory requirements.
  • Strong analytical problemsolving and troubleshooting skills.
  • Excellent attention to detail and the ability to work efficiently in a fastpaced compliancedriven environment.
  • Effective communication skills and ability to collaborate with crossfunctional teams.
  • Ability to work independently with minimal supervision and take initiative in resolving issues.

Preferred:
  • Experience in stability studies method validation and handling of highvalue API materials.
  • Certification in Quality Management or related fields (e.g. Six Sigma ISO).
  • Experience with preparing and handling documentation for regulatory submissions.

time management,uv-vis,analytical thinking,project coordination,cgmp,hplc,team collaboration,gc,problem solving,adaptability,decision making,stability studies,glp,laboratory equipment maintenance,titrations,quality control,analytical data interpretation,method validation,quality control testing,communication,quality management,confidentiality

Employment Type

Full Time

Company Industry

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