Job description

Job Description

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.

‘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.

Job Title: Senior QA Specialist

· This position will provide QA technical support for External Manufacturers (EM) European, Latin America or North America Region. Review and approve quality system documents including SOP, specification and manufacturing instructions.

· Responsible for product release, ensuring products meet cGMP, Janssen specifications and regulatory requirements.

· Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety.

· Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required.

· Responsible for continuous improvement and risk management activities of EM.

Key Responsibilities:

· Reviewing batch documentation and product release

· Conducting and participating in manufacturing investigations.

· Reviewing and approving EM deviations

· Developing corrective action plans and monitoring implementation

· Review and approve change control

· Writing and implementing of quality procedures

· Identifying and implementing continual improvements of manufacturing and quality/compliance processes

· Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time

· Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation

· Participating in quality audits at external manufacturers

· Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk.

· Participate and support escalation process and issue management process

· Support regulatory inspections, manage JJRC reporting and monitor follow up on regulatory commitments

· Maintain Quality Agreement and specification changes.

Qualification:

· A Bachelor's or equivalent University degree is required with a focus in engineering, science or equivalent technical discipline preferred.

Experience & skills required:

· Demonstrates knowledge of Quality Assurance, Quality Control and Compliance

· A minimum of 6 years relevant work experience

· Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issue

· Experience in applying process excellence tools and methodologies

· Proficient in written and spoken English Preferred:

· Experience in the development, implementation, and review of SOPs for interactions with contract manufacturers

· Advanced degrees in engineering, science, or an equivalent technical

· Experience investigating customer Product Quality Complaints

· Experience in pharmaceutical / biologics manufacturing or quality environment

· Other: Requires up to 25% domestic and international travel (optional)

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: On the road

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