QA Csq/cqv Lead

**QA CSQ/CQV Lead**

My client is a premier provider of vaccine services, covering the entire spectrum from discovery to commercialization. Their global reach extends to biopharmaceutical and healthcare industries, with a reputation as one of the world's top three contract development and manufacturing companies for biopharmaceuticals. With a commitment to open access technology, they empower clients to advance drug research, development, and manufacturing. The mission is to accelerate the progress of biologics, benefitting patients worldwide, and our multi-national presence includes sites in China, the US, the EU, Asia, and Israel. Employing over 10,000 professionals, we proudly serve more than 200 customers, including 13 of the top 20 biopharmaceutical companies.

**Role Overview**
As a **QA CSQ/CQV Lead**, you will play a pivotal role in ensuring the quality and compliance of validation and equipment qualification activities within the company. This role involves overseeing computerized systems and lab equipment qualification, aligning with all relevant regulations, company policies, and contractual obligations. By reviewing and approving commissioning and qualification activities, you'll contribute to the meticulous execution of validation lifecycle documents.

**Department Description**
As QA CSQ/CQV Lead, you'll join an inclusive organization that values diverse backgrounds and experiences. Together, we focus on making a positive impact on lives. In this role, you'll report directly to QA Director, collaborating closely to achieve our quality assurance goals.

**Responsibilities**

In this role, you will:

- Oversee validation and equipment qualification activities, ensuring compliance with regulations and obligations.
- Review and approve commissioning and qualification activities, encompassing the validation lifecycle process.
- Provide guidance for creating equipment lifecycle documentation, including protocols, assessments, and technical specifications.
- Participate or lead investigations related to qualification discrepancies.
- Review and approve SOPs, deviations, and other key quality documents.
- Participate in customer audits and regulatory inspections.
- Collaborate with internal and external stakeholders to ensure effective communication.
- Align with company's quality strategy and contribute to continuous improvement.
- Fulfill additional tasks as directed by the QA department management.
- Minimum of a bachelor’s degree in biology, biotechnology, or a relevant discipline.
- A minimum of 6 years of QA experience in the biotech/pharmaceutical industry, with preference given to those with vaccine or biologics experience.
- Strong understanding of cGMP requirements, GCPs, GLPs, GAMP, and Part 11 compliance.
- Excellent knowledge of validation principles and industry best practices.
- Familiarity with audit challenges and regulatory inspections.
- Effective problem-solving skills and adaptability in a fast-paced environment.
- Exceptional written and oral communication skills for cross-functional interaction.

**For further information, contact Alan on**
**/ 087 365 7522