Project Manager- CQV

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.

Key Responsibilities:

1. CQV Consultancy Activities

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Compile and reviewthe followingin line with EU GMP and ISPE guidelines–

o Project Quality Plan

o Quality Risk Assessment Plan

o Critical Quality Attributes report

o Critical Process Parameters report

o Critical Control Points report

o Contamination Control Strategy report

o UserRequirement Specification

o Validation Master Plan

o Computer System Validation Plan

o VendorManagement Plan

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Review protocol and report for FAT/SAT

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Generate and review IQ and OQ protocols

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Design SOPs for OQ elements

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Generate and review PQ protocol and report

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Closure of validation risk assessment and issue system/equipment release certificate

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Develop PV strategy,protocols,and risk assessment

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Prepare final PV report

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Develop, execute and report regularlyontesting plans as per Validation Master Plan

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Responsible for the IQ, OQ and PQ test implementation for HVAC system

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Responsible for the compressed air and pure steam PQ testing

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Responsible for the process equipment PQ testing

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Resource management of validation testing

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Deviations/CAPA management

2. QMS ImplementationActivities

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Responsible for designing and implementing a QMS and document systemin line withEU, WHO PICS GMP standards

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QMS implementation shall focus on simplified integrated SOPs and BMRs to ensure they are accurate and easy to follow and shall meet requirementsofgood data integrity and governance practices as per global GMPs

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Generate and execute a training program to ensure system users are fully qualified and compliant in system use

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Preparation if quality manual and site master file

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Pressure testing the quality system to identify and mitigate gaps in advance of pre-approval

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Defend the quality system to regulatory authorities

Requirements

• Bachelors or higher degree in a Science, Engineering or Other related Technical discipline
• Minimum 10 years of previous experience in CQV in Pharma/Biotech Industry
• Minimum 5 years of experience in Project ManagementAbility to analyse data and make recommendations
• Experience in working with cross functional teams
• Excellent report, standards, technical writing skills
• Proficiency in Microsoft Office suite and job-related computer applications required