Quality Assurance 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
• 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.

Requirements

• A contract role for a Specialist, Quality Assurance
• Responsible for activities including some or all of the
• following and any other tasks as required:
• Ensure data integrity principles: Attributable, Legible,
• Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and
• data in day-to-day business
• activities.
• Attend and successfully complete applicable cGMP
• training.
• Responds to Operational and business area’s, drives
• compliance with cGMP and corporate regulations.
• Drives cGMP/GDP compliance in the performance of
• day-to-day business activities.
• Escalate any potential violation of cGMP and/or other
• concerns which may affect the safety, efficacy, quality, or purity of human
• health products and aids resolution
• Liaise with the Quality/ Business Area Specialists/QP/QA
• Lead to resolve quality related queries where required
• Provides expertise & quality support for the
• introduction of new products onto site in relation to product release where
• required
• Ensure and promote that adequate processes and procedures
• are in place and followed for all Quality activities.
• Report on and assist with monitoring the Quality
• Management Systems. Generate reports for performance metrics and significant
• quality events & issues.
• Review and approval of all manufacturing batch/ material
• documentation
• including electronic batch records, real time reports,
• master data using the site systems where required.
• Identify, influence and support compliance initiatives to
• improve compliance status and overall operational efficiency for batch release
• at the site.

Education

• Bachelor's degree in Science, Engineering, Quality,
• Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related
• technical discipline.
• Relevant industry qualifications or certifications in
• Quality Management Systems, Compliance, Auditing, or Operational Excellence are
• desirable.

Experience

• Typically 3 to 5 years' experience in a regulated
• pharmaceutical, biotechnology, medical device, or healthcare manufacturing
• environment.
• Demonstrated experience working within Quality Systems
• and Compliance
• functions, including management of quality records,
• deviations, CAPAs, change controls, investigations, Complaints and document
• management systems.
• Knowledge of current GMP requirements and quality system
• standards applicable to pharmaceutical manufacturing.

Experience collaborating with cross-functional teams

including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical

Operations.

Skills and Competencies

• Strong understanding of Quality Management Systems and
• GMP compliance requirements.
• Excellent analytical and problem-solving skills with the
• ability to evaluate complex quality issues and identify sustainable solutions.
• Strong written and verbal communication skills, including
• technical writing and report preparation.
• Ability to manage multiple priorities and deliver results
• within agreed timelines.
• Effective stakeholder management skills with the ability
• to influence across functions and levels of the organization.
• Strong attention to detail and a commitment to
• maintaining data integrity and quality standards.
• Ability to interpret regulatory requirements and
• translate them into practical site procedures and processes.
• Proficiency in Microsoft Office applications and
• electronic quality management systems.
• Demonstrated capability to drive continuous improvement
• and support a culture of quality and compliance.

Preferred Experience

Experience with site Quality Systems governance, metrics,

compliance monitoring, and inspection readiness activities.