Associate Manager QA Validation-(Cleaning Validation) R12863

About PSC Biotech Ltd

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. Our client is currently looking for a highly talented professional to join their team on a permanent basis with an attractive benefits package.

Employee Value Proposition

We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Our client is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.

Our mission is to use the power of science to bring new medicines to our patients.

Summary: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversees a team of ValidationSpecialists.

Asan Associate Manager in QA Validation, a typical day may include:

Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.

Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.

Ability to lead multiple and sophisticated validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.

Lead technical and quality investigations.

Collaborates with functional departments to resolveissues.

Managea cross-functional project with many stakeholders

Reviews, edits and approves change controls, SOPs, reports and other documentation

Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

Trains/advises less experienced Specialists.

May present at both internal and external (regulatory) audits if required.

Stays current with industry trends, regulatory requirement updates, and presenting same to team

Performs other duties assigned byManagement.

Sometravel may be required.

Requirements

Education and Experience:

BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the field preferred; may substitute relevant experience for education.

Previous team/people management experience essential.

Previous cleaning validation and steam in place experience an advantage.

Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.