Quality Assurance Specialist - Pharmaceutical Organization
We are currently seeking a highly skilled Quality Assurance Specialist to join our team in the pharmaceutical industry.
1. The successful candidate will be responsible for ensuring compliance with current regulatory requirements and cGMP standards, overseeing all validation activities, and reviewing documentation and data associated with qualification/validation activities.
2. Strong technical aptitude and deep knowledge of GxP regulations applicable to biologics manufacturing is required. Thorough understanding of validation requirements associated with a cGMP manufacturing facility is also necessary.
3. Knowledge of troubleshooting and problem-solving skills, formal root cause analysis methods and tools such as Ishikawa diagrams, FMEA etc., will be beneficial.
Key Responsibilities:
* Ensure quality oversight of qualification/validation activities of facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, CTUs, and shipping processes.
* Review validation documentation and associated data, including plans, URSs, quality risk assessments, protocols, and reports, for conformance to SOPs, specifications, and other applicable acceptance criteria.
* Provide QA oversight on events/deviations, investigations, and change evaluations during qualification/validation activities.
Qualifications:
* Bachelor's degree in a scientific or engineering related discipline.
* At least 3 years of experience in a quality engineering/quality assurance/quality validations role for biologics or pharmaceutical/medical device manufacturing in a FDA/EU regulated environment.
This is an excellent opportunity for individuals who have strong analytical and problem-solving skills, attention to detail, and the ability to work effectively in a team environment.