What are the responsibilities and job description for the Quality Specialist position at TekOne IT Services Pvt. Ltd.?
- Review and approve batch records to ensure compliance with quality standards and regulatory requirements.
- Document and investigate deviations, ensuring timely resolution and implementation of corrective actions.
- Manage change controls and ensure all changes are properly documented and reviewed.
- Collaborate with cross-functional teams to facilitate quality improvement initiatives.
- Support the preparation and maintenance of quality documentation.
- If extended beyond 6 months, assist in training for batch record release work.
Education:
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, or a related field (preferred).
- 4-8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Demonstrated experience in batch record review, deviation management, and change control processes.
- Strong understanding of cGMP regulations and quality standards.
- Excellent attention to detail and ability to analyze complex data.
- Strong written and verbal communication skills for effective documentation and collaboration.
- Ability to work independently and as part of a team.
- Manager references required to validate experience and performance.
- Candidates must be flexible and able to adapt to changing priorities.
