Warehouse Compliance Specialist

1 week ago

Carlow, Ireland PSC Biotech Ltd Full time

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.



Role Description:

To provide compliance support for the SCM/Warehouse/Weigh and Dispense with respect to Standard Operating Procedures, Receipt documents, Shipping documents, protocols/reports to ensure processes and end products comply with corporate and regulatory requirements to facilitate material handling. Ensures SCM/Warehouse/Weigh and Dispense documentation practices are compliant with client's site specific and regulatory requirements.



Requirements

Role Functions:

  • Work as directed by the Warehouse & Weigh and Dispense Area Manager(s) according to Company safety policies and cGMP. Required to drive compliance with clientGlobal policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Required to comply with client Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Provide support for the SCM/Warehouse/Weigh and Dispense with respect to the following:
  • Support the updating of Standard Operating Procedures, Shipping & Receipt Documents, protocols and associated reports and any other documentation/ administration of these documents in direct support to the SCM/Warehouse/Weigh and Dispense.
  • Review of eLogs
  • Archiving/retrieval of the SCM/Warehouse/Weigh and Dispense documentation.
  • Maintaining and controlling the SCM/Warehouse/Weigh and Dispense documentation areas.
  • Acts as compliance point of contact for all SCM/Warehouse/Weigh and Dispense documentation topics.
  • Assist in the review of SCM/Warehouse/Weigh and Dispense operational procedures, training materials and procedures for various systems.
  • Support documentation in support of investigations, non-conformances, protocols, reports and change controls.
  • Assist in the review of data for periodic reviews as required.
  • Drive continuous improvement for all aspects of documentation control/ archival.
  • Contribute to the achievements of department productivity and quality goals.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Liaise with site QA Document Control group.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.
  • Participate in SCM/Warehouse/Weigh and Dispense Tier daily meetings and ensure effective communication of relevant information.
  • Completion of Projects in an efficient and timely manner as agreed with the area manager.
  • Work collaboratively to drive a safe and compliant culture.
  • May be required to perform other duties as assigned.

 

Experience, Knowledge & Skills:

  • 3-5 years’ experience in a quality role (QC/ QA), ideally in a pharmaceutical manufacturing environment.

 

Core Competencies:

Technical:

  • Knowledge of cGMP and GDP preferred
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Extensive knowledge of the following systems:
  • Change Control
  • Deviation Management
  • Self-Inspections
  • Knowledge of cGMP and GDP required.
  • Report, standards, policy writing skills required.

 

Business:

  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports.
  • Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • Planning and scheduling skills
  • Flexible approach
  • Proven organizational skills.
  • Starter, Finisher
  • Effective time management and multi-tasking skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Goal/results orientated.
  • Training skills

 

Leadership:

  • Focus on Customers and Patients
  • Collaborate
  • Act with Candor and Courage
  • Make Rapid, Disciplined Decisions
  • Drive Results
  • Build Talent
  • Demonstrate Ethics and Integrity

 

Qualifications & Education:

  • Bachelor’s Degree with 3+ years’ experience in Pharma and Compliance or
  • Leaving Cert with years’ experience in Pharma and Compliance


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