What are the responsibilities and job description for the Pharmaceutical Compliance Manager position at CSL Seqirus?
Role Overview
As a Front Line Quality Assurance (FLQA) Specialist at CSL Seqirus, you will play a critical role in ensuring the quality and integrity of our influenza vaccine production. This includes providing quality assurance support for manufacturing, laboratories, warehouse, and utility operations, and ensuring compliance with regulatory requirements and quality standards.
Key Responsibilities
As a FLQA Specialist, you will be responsible for:
* Ensuring the robust investigation, identification of root cause, and development and execution of strong and robust CAPAs and change controls
* Performing routine quality walkthroughs and monitoring quality system adherence
* Functioning as primary FLQA and Quality Management System (QMS) subject matter expert to assigned areas of responsibility
* Participating in cross-functional suite team meetings and providing FLQA support for suite team projects and initiatives
Requirements
* Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) or equivalent experience in biotech or pharmaceutical industry
* 3 years' GMP experience in pharmaceutical/biotech industry
* Previous experience in vaccine manufacturing operations and/or QC laboratories preferred
* Demonstrated knowledge of cGMPs, FDA requirements, and Quality Systems
Our Culture
At CSL Seqirus, we value our employees and offer a dynamic work environment that supports professional growth and development. We are committed to making a difference in people's lives through our innovative products and services.
As a Front Line Quality Assurance (FLQA) Specialist at CSL Seqirus, you will play a critical role in ensuring the quality and integrity of our influenza vaccine production. This includes providing quality assurance support for manufacturing, laboratories, warehouse, and utility operations, and ensuring compliance with regulatory requirements and quality standards.
Key Responsibilities
As a FLQA Specialist, you will be responsible for:
* Ensuring the robust investigation, identification of root cause, and development and execution of strong and robust CAPAs and change controls
* Performing routine quality walkthroughs and monitoring quality system adherence
* Functioning as primary FLQA and Quality Management System (QMS) subject matter expert to assigned areas of responsibility
* Participating in cross-functional suite team meetings and providing FLQA support for suite team projects and initiatives
Requirements
* Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) or equivalent experience in biotech or pharmaceutical industry
* 3 years' GMP experience in pharmaceutical/biotech industry
* Previous experience in vaccine manufacturing operations and/or QC laboratories preferred
* Demonstrated knowledge of cGMPs, FDA requirements, and Quality Systems
Our Culture
At CSL Seqirus, we value our employees and offer a dynamic work environment that supports professional growth and development. We are committed to making a difference in people's lives through our innovative products and services.
