Quality Control Validation Specialist

Responsibilities:

Method Development and Qualification/Validation: Lead the design, development, and qualification/validation of analytical methods aimed at assessing critical quality attributes of raw materials, drug substances, intermediates, and products.

Data Processing: Skillfully process data generated from Qualification and Validation, ensuring accurate and comprehensive report generation.

Regulatory Compliance: Ensure that the evaluation and testing of GBI products align with regulatory standards, scientific best practices, and are completed within established schedules.

Documentation Oversight: Review, write, and supervise the execution of input and output reports and Standard Operating Procedures (SOPs).

Timely Data Finalization: Ensure that all analytical raw data is reviewed and finalized within the stipulated timeframes.

Requirements :

Minimum of five years of direct work experience in an FDA-regulated environment.

Problem-Solving: The candidate should be a proficient problem-solver, demonstrating the ability to exercise sound judgment under challenging circumstances.

Communication: Excellent written and verbal communication skills with the ability to effectively promote cooperation within and between departments.

Regulatory Knowledge: In-depth knowledge of GMP, ICH, and compendial requirements and their application for the Qualification and Validation of Analytical methods for Large Molecules.

Attention to Detail: Strong attention to detail, observation, organizational, and leadership skills.

Personal Integrity: Possess strong character with self-confidence and integrity.

Time Management: Demonstrated time management skills to ensure efficiency in project execution.

Critical Thinking: The ability to think critically and make informed decisions based on analytical assessments

Bachelor's degree in biological or biochemical sciences or a related field.