Quality Assurance Associate
Position : Quality Assurance Associate / Junior Quality Assurance Specialist
Job Summary :
The Quality Assurance Associate / Junior Quality Assurance Specialist is responsible for supporting the implementation and maintenance of quality systems and ensuring compliance with regulatory requirements.
They assist in the execution of quality processes and contribute to the overall quality control and quality assurance activities within the organization.
Responsibilities :
Assist in the development and implementation of quality systems, policies, and procedures in compliance with applicable regulations and guidelines.
Support the review and approval of manufacturing and testing documents, including batch records, protocols, specifications, and standard operating procedures (SOPs).
Participate in the execution of quality control activities, such as sampling, testing, and inspection of raw materials, intermediates, and finished products.
Assist in investigations of deviations, out-of-specification results, and non-conformances, and contribute to the implementation of corrective and preventive actions (CAPAs).
Support the maintenance of the document control system, ensuring accurate and up-to-date records of quality-related documentation.
Assist in internal audits and participate in regulatory inspections, as required.
Contribute to the training and awareness programs related to quality systems and Good Manufacturing Practices (GMP) for employees.
Assist in the monitoring and trending of quality data, including quality metrics and key performance indicators (KPIs).
Collaborate with cross-functional teams, including Manufacturing, Quality Control, Regulatory Affairs, and R&D, to ensure effective communication and resolution of quality-related issues.
Stay updated on regulatory requirements, industry trends, and best practices related to quality assurance.
Requirements :
Bachelor's degree in a relevant scientific field, such as Pharmacy, Chemistry, or Life Sciences.
Basic understanding of GMP and regulatory guidelines in the pharmaceutical industry.
Strong attention to detail and ability to follow procedures accurately.
Good communication skills, both written and verbal.
Ability to work effectively in a team-oriented environment.
Proficient computer skills, including MS Office applications.
A proactive and self-motivated approach to work, with a willingness to learn and grow in the field of quality assurance.