Quality Assurance Technician

Job Description Quality Assurance Technician

Responsibilities

Conduct quality assurance activities for all pharmaceutical products developed by VeV Scientific, including but not limited to drug development, clinical research, and manufacturing processes Managing, coordinating, facilitating and implementing quality assurance standards based on applicable FDA, ICH and ISO requirements

Develop and implement quality control procedures to ensure compliance with company standards, industry regulations, and legal requirements

Collaborate with cross-functional teams to identify and resolve quality issues and implement corrective and preventive actions

Conduct risk assessments and make recommendations for process improvements to enhance product quality and safety

Monitor and analyze quality metrics to identify trends and areas for improvement

Conduct internal and external audits to assess compliance with quality standards and regulations

Initial contact and quality control resource for quality event or nonconformance identification, report write-up and quality event documentation/investigation

Review and approve documentation related to product development, including protocols, validation reports, and batch records

Participate in the initiation, documentation, and management of quality events (e.g. deviations, CAPA, change control, complaints, product returns/recalls)

Proposes appropriate correction, corrective action plans and measures and effectiveness verification for CAPA/Deviation resolution and closure

Train and educate employees on quality procedures and best practices

Stay updated on industry trends and regulations related to pharmaceutical product development and incorporate them into the company's quality processes

Communicate effectively with team members, management, and external stakeholders to ensure understanding and alignment on quality objectives

Support regulatory inspections and assist in responding to any findings related to quality

Maintain accurate and up-to-date records of all quality-related activities

Continuously identify opportunities for process improvement and participate in cross-functional initiatives to implement them

Review/release regulatory document packages (including batch records, CoAs and other related documents) for each product

Generates/signs/approves applicable records including Certificate of Conformance and/or Certificate of Analysis for product lot/batch releases

Qualifications

Bachelor of Science

Must have excellent skills in organization, negotiation, problem solving and time-management

Able to attend to detail and act decisively

Must have excellent interpersonal, written, oral presentation and verbal communication skills

Proficient in Microsoft Word, PowerPoint, Access and Excel