QA Specialist
The successful candidate will be responsible for providing overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
Responsibilities:
* Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities.
* Validation Plans, Protocols, IQ, OQ, PQ and associated documents.
* Executed validation documents and reports.
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet company and regulatory expectations.
* Provide Quality direction and input at Change Control Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
* Quality review/approval of BOMs, MBRs and recipes.
* Write, review and approve Standard Operating Procedures in accordance with company Policies.
Qualifications:
* University degree. Science or engineering related discipline is preferred.
* 7 years + relevant experience working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.
* Understanding of principles of Validation and New Product Introduction.
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
* Critical thinking skills.
* Strong organizational, communication, coordination, and meeting facilitation skills.
* Team players are prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Seniority level: Entry level
Employment type: Full-time
Job function: Quality Assurance and Science
Industries: Pharmaceutical Manufacturing
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