Pharmaceutical Quality Specialist

1 week ago

Bavla, India beBeeFormulation Full time ₹ 20,00,000 - ₹ 30,00,000

Quality Control Formulation Manager Role

Job Summary:

This role oversees and manages day-to-day Quality Control operations for the formulation unit, ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). The successful candidate will support the company's quality standards and regulatory requirements.

Main Responsibilities:

  • Manage laboratory activities to ensure adherence to testing schedules and timelines.
  • Ensure GLP, GMP, and internal quality standards are met during analytical and documentation activities.
  • Oversee sampling, testing, and release of raw materials, packaging materials, in-process samples, finished products, and stability samples.
  • Review and approve analytical results, test protocols, and validation reports.
  • Maintain accurate laboratory records and electronic systems.
  • Investigate and close quality management system-related activities, including deviations, out-of-specifications (OOS), out-of-trend (OOT) results, laboratory incidents, and CAPAs.
  • Lead, train, and mentor a team of QC analysts and junior staff.
  • Promote a culture of continuous improvement, accountability, and quality excellence within the lab.

Requirements:

  • Bachelor's or Master's degree in Pharmacy, Chemistry, or related field.
  • Minimum 7-10 years of experience in a Quality Control role within a pharmaceutical formulation environment, with at least 2-3 years in a managerial capacity.
  • In-depth understanding of GLP, GMP, and regulatory guidelines (e.g., USFDA, MHRA, WHO).

Key Skills:

  • Strong analytical and problem-solving skills.
  • Excellent communication and leadership skills.
  • Ability to work in a fast-paced environment.
  • Knowledge of laboratory information management systems (LIMS).

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