Quality Assurance Specialist
Our company is seeking a Quality Assurance Specialist to join our team. This role will be responsible for ensuring the quality of our products and processes, as well as identifying and implementing improvements.
Key Responsibilities:
* Execute cleaning cycle development and qualification of equipment.
* Develop and implement validation strategies, collaborate with external vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
* Run business activities such as periodic reviews of equipment, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
* Provide support during commissioning phases by reviewing and approving documents. Ensure documentation complies with relevant standards.
* Participate in cross-functional problem-solving teams for troubleshooting and investigations within the Vaccines IPT.
* Prepare technical reports, perform statistical analysis of data.
* Comply with the latest regulatory guidelines.
* Represent the IPT on cross-functional project teams.
* Offer technical input and support, and present as a Subject Matter Expert on relevant topics during regulatory inspections.
* Ensure compliance with site EHS policy, cGMP and other business regulations, and support Technical IPT input to risk assessments, audits, regulatory inspections, and incident investigations.
* Ensure the highest Quality, Compliance, and Safety standards by participating in and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership as relevant.
Required Skills and Qualifications:
* Experience as a quality assurance specialist in a pharmaceutical or highly regulated environment and a Bachelor's Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
* Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations, manufacturing, Process Engineering.
* A working knowledge of the GxP systems associated with this role would be advantageous. These include but are not limited to GLIMS and eVAL, electronic batch records.
If you're interested in this opportunity, please contact us for further information.