QA Validation specialist

About PSC Biotech

Who are we

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.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our clients expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

A fantastic opportunity has arisen for a Quality Assurance Validation Specialist. You will support new Validation and Commissioning programs across site as well as the periodic review of validated systems within the Drug Substance Facilities and laboratories to ensure ongoing compliance to cGLP and cGMP.

This role will be key in supporting the day to day running of the Validation dept Laboratories and Projects to ensure that processes are streamlined and business objectives adhered to. You will be the key in driving QA compliance to ensure standards are best in class across our industry a benchmark for others to aspire to. You will support the specialist role function in each area. Bring energy knowledge innovation to carry out the following: Work as directed by the Quality Assurance Validation lead according to company safety policies cGMP and cGLP.

Collaborate with project-based teams Validation Microbiology IT Engineering utilities and other departments to provide QA support for commissioning decommissioning and Validation project across site.

Responsible for the approval of Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.

Responsible for the approval of Validation Lifecycle documents and reports supporting Temperature mapping EMPQ and AVS studies

Provide Quality oversight of Periodic review and Equipment revalidation.

Provide real time review of commissioning test scripts and escalate issues in a timely manner to CQV and QA leadership as appropriate.

Support the Site Calibration program

Act as Quality Assurance point of contact for Cleaning Validation WFI PQ and PQ of process equipment including Filter Integrity parts washers Autoclaves and process Validation studies etc.

Act as a Champion for developing a Data Integrity Culture across site.

Working Knowledge of GMP regulatory guidelines with the ability to accurately interpret and provide quality guidance for validation activities in the drug substance and laboratory areas

Any other tasks as directed by QA Validation Lead.

Requirements

What skills you will need:

In order to excel in this role you will more than likely have:

Min of a BSc Degree in relevant Science. MSc preferable.

Min. 1 year Validation / CQV experience.

The following experience is desirable:

Experience and expertise that add value to the business; Chemistry Chemical Eng Biological science Biotechnology in a Biopharmaceutical GMP setting.

Knowledge of cGMP Process & utility Quality Systems.

Knowledge of Deviation management Change Management Risk Management.

KNEAT Cleaning Validation Environmental Monitoring Filter Validation studies and Single use equipment as distinct advantage.

Knowledge of regulatory guidelines supporting Drug substance manufacturing: ICH EU and FDA.

Strong technical writing skills required.

Effective communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

Ability to work independently in a high-paced team environment meet deadlines and prioritize work from multiple projects. Ability to work with management locally and globally.