What are the responsibilities and job description for the Quality Assurance position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
- Review SOPs: Evaluate and update standard operating procedures and other related administrative documents to ensure accuracy and compliance.
- Batch Review: Conduct thorough reviews of batch records and manufacturing processes to verify compliance with regulatory requirements and internal standards.
- Collaboration with CSV Team: Review work performed by the Computer System Validation (CSV) team to ensure software systems meet quality assurance standards.
- Audit Support: Assist in review and audit processes, providing necessary documentation and insights to support compliance efforts.
- Quality Reviews: Conduct quality reviews of documentation and processes to identify areas for improvement and ensure adherence to quality standards.
- Communication: Maintain excellent communication skills, particularly in writing, to produce clear, concise, and comprehensive reports and documentation.
- Education: Bachelor’s degree in Life Sciences, Quality Assurance, or a related field preferred.
- Experience: Minimum of 3-5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Knowledge of Regulations: Familiarity with FDA regulations, cGMP, and quality management systems.
- Attention to Detail: Strong attention to detail and analytical skills to identify discrepancies and ensure compliance.
- Communication Skills: Exceptional verbal and written communication skills, with a focus on producing high-quality documentation.
- Team Player: Ability to work collaboratively in a team-oriented environment and interact effectively with cross-functional teams.
