Senior QA Validation Specialist Cleaning Validation R15326

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.

The client s 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.

The client s mission is to use the power of science to bring new medicines to our patients

Summary: Validate/qualify cleaning processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

As a Sr QA Validation Specialist, a typical day may include:

Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria

Oversees cleaning validation for program to ensure program adherence in accordance with approved schedules.

Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

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

Effectively communicate to key stakeholders on cleaning validation programs (program adherence, success rate, issues / roadblock.

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

Coordinates with other departments or outside contractors/vendors to complete validation tasks.

Trains/advises less experienced Specialists.

Manages projects and prepares status reports.

May be required to oversee contingent workers.

Other duties assigned by management.

Knowledge Skills & Abilities:

Ability to maintain integrity and honesty at all times

Ability to work independently or as part of a team

Ability to communicate with transparency

Continuously drive to improve processes for improved performance

Demonstrate respectful behavior at all times

Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint)

Gathers and organizes information

Meets commitments on time

Follows directions; performs well-defined tasks

Effective time management skills

Seeks to identify continuous improvement needs

Requirements

To be considered for this role you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the field preferred; may substitute relevant experience for education.

Benefits