Quality Specialist

3 weeks ago

india PSC Biotech Ltd Full time
Job Description

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 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 points 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 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.


#LI-DM2
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. #LI-DM2

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