Quality Specialist

About PSC Biotech

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 cloudbased 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 points which includes the opportunity to work with the most talented cohort of likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. 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.

Job Purpose:

The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the client site.

Requirements

Key Result Areas and Primary Activities:

Review and approve production and analytical documentation accompanying the release of drug substance drug product and packaged finished goods to ensure conformance to appropriate SOPs GMP and regulatory requirements including supporting QP certification.

Perform and review complaints and deviation investigations change controls and CAPA s.

Creates and maintains assigned SOPs.

Compiles data for reports and presentations provides data interpretation draws conclusions.

Completes audits to ensure compliance to SOPs GMPs and applicable regulations.

Support product recalls and stock recoveries as appropriate.

Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.

Identify compliance gaps and make recommendations for continuous improvement.

Assists in the induction process for new starters and training of other staff.

Generally follows standard procedures and consults with manager/supervisor on exceptions.

Carries out all assignments to the standards of compliance efficiency innovation accuracy and safety in accordance with Company and regulatory requirements.

Keeps abreast of cGMP requirements as described in applicable worldwide regulations.

Represents department on cross functional teams.

Additional activities as assigned by the manager/supervisor.

Skills Required:

The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience.

Alternatively they must possess considerable industrial experience.