Job Title: Quality Assurance Assistant
This is a role within the Quality Assurance Department, responsible for ensuring adherence to current Good Manufacturing Practices (cGMP) and Environmental, Health, and Safety (EHS) practices.
Duties:
* Administration of the Documentation Control System and maintenance of related files throughout their lifecycle.
* Maintenance of the Quality Management System (QMS) and use of associated software (Pragma and Adhoc).
* Review of manufacturing and cleaning records to ensure compliance with cGMP.
* Review of shipment documentation and containers prior to release to ensure accuracy.
* Issuance of materials such as intermediates to production in accordance with QMS procedures.
* Performance of Good Manufacturing Practice (GMP) Walkthroughs as scheduled.
* Review of temperature and humidity data to ensure compliance with storage requirements.
* Provision of proactive reporting and responses to quality-related issues in a timely manner.
* Assistance with sourcing and preparation of quality documentation such as product quality reviews and QMS processes like change controls.
* Performance of cleaning visual inspections to ensure compliance with GMP standards.
* Provision of training to others as required to enhance knowledge and skills.
* Assistance with audit preparation to ensure readiness and compliance.
* General administrative duties for the Quality Assurance department, including filing and record-keeping.
* Performance of other duties assigned by the supervisor or designee.
Responsibilities:
* To adhere to cGMP and EHS practices at all times, maintaining a safe working environment.
* To liaise with supervisors to ensure rapid communication of issues and progression of projects, documentation updates, etc.
* To maintain the Documentation Control System, updating documentation as per change control and adhering to Good Documentation Practices.
* To critically review manufacturing, cleaning, and shipment documentation to ensure adherence to cGMP, addressing any outstanding issues prior to release.
* To assist other department members with quality documentation and QMS processes as needed.
* To perform general administrative duties for the department, ensuring accurate record-keeping and filing.
* To demonstrate a general interest in quality assurance activities and a desire for improvement opportunities.
Working Conditions:
This position is primarily office-based within the Quality Assurance Department, with some duties performed within the GMP areas, such as production, quality control, and warehouses. The company will provide a safe working environment, and all personnel are expected to comply with current standard operating procedures and cGMP as required.
Work Performance:
* Timekeeping and attendance will be monitored.
* Work output and quality of workmanship will be evaluated.
* Compliance with agreed work schedule and program will be assessed.
* Health, Safety, and Environmental and Quality practices will be followed.
* Ability to work in a team environment and independently will be evaluated.
* Work attitude, training, and self-development will be considered.
* Contribution to improving the department will be acknowledged.
* Overall team performance will be reviewed.
The Quality Assurance Assistant Manager will conduct regular Performance Reviews to discuss performance, identify areas for improvement, and set objectives.