Associate Quality Specialist

2 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 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.


Associate Quality Specialist supports day to day QA activities in the facility.


Requirements

Responsibilities: 


  • Participate as functional expert in the cross functional team that manages production right first time.

·      Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.

·      Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.

·      Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.

·      Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.

·      Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.

·      Ensure change controls raised are documented, assessed and completed.

·      Prepare Annual Process and System Reviews.

·      Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.

·      Participate in the generation and communication of quality metrics.

·      Creation, review and approval of quality procedures as required.

·      Review and approve batch, cleaning and testing documentation.

 

 

Competencies:
  • Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
  • Team Work: Interacts with people effectively. Able and willing to share and receive information.
  • Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
  • Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
  • Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
  • Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self direction.


Skills:

  • Degree or post-graduate qualification in Science, Pharmacy or equivalent.
  • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems).
  • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  • Experience and knowledge of GMP Requirements for Electronic /paper free operations.

 

#LI-EL1


Requirements
POSITION RESPONSIBILITIES Participate as functional expert in the cross functional team that manages production right first time. · Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. · Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives. · Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. · Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments. · Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes. · Ensure change controls raised are documented, assessed and completed. · Prepare Annual Process and System Reviews. · Act as lead/team auditor to support the internal GMP walkdown and scheduled audits. · Participate in the generation and communication of quality metrics. · Creation, review and approval of quality procedures as required. · Review and approve batch, cleaning and testing documentation. COMPETENCIES Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately. Team Work: Interacts with people effectively. Able and willing to share and receive information. Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed. Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people. Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self direction. Skills: Degree or post-graduate qualification in Science, Pharmacy or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, Document Management Systems). · Knowledge and demonstrated expertise in Lean / Continuous Improvement. · Experience and knowledge of GMP Requirements for Electronic /paper free operations.

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