Senior Compliance Specialist
This is a critical role in ensuring site operational activities are compliant and executed according to site procedures.
Main Responsibilities:
* Provide quality oversight and support for operations, ensuring GMP activities comply with regulatory and corporate procedures.
* Offer on-site support and guidance for GMP product quality assurance and compliance.
* Review and approve batch records, cleaning records, and other key documents.
* Ensure compliant systems and processes are in place and executed as intended.
Required Skills and Qualifications:
* Undergraduate degree in pharmaceutical, biological, or chemical sciences.
* Relevant advanced degree preferred.
* 5+ years of experience in the Pharmaceutical industry, with current knowledge of cGMPs required.
* Experience in equipment commissioning/qualification, cleaning validation, and process validation desirable.
This role will work closely with cross-functional teams to develop and implement standard work and ensure compliance across the site.
Key Benefits:
* Opportunity to work with a dynamic team to drive quality and compliance initiatives.
* Chance to develop and apply expertise in quality assurance and regulatory compliance.
Other Requirements:
* Strong written and oral communication skills.
* Ability to collaborate effectively with others.
* Strong interpersonal, leadership, and influencing skills.