Senior Contract

2 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 4-5 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
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 Title: Senior Contract & Development Manager

Job Summary:

· This position will report to the Contract &Development Manager Manufacturing. The ideal candidate will have previousexperience in aseptic processing in a sterile manufacturing facility with cGMPand Quality System knowledge.

· The candidate will have excellenttroubleshooting skills using standard industry techniques

· Position will be responsible for managing andexecuting nonconformance, CAPA, SICAR, Change Control and metrics oversightresponsibilities for the External Supply organization

· Determines situations which require escalationto management

· Communicate with all levels of the organization,facilitate development of solutions to critical business issues, andeffectively define objectives to enable effective metric generation andreporting.

· Facilitate daily scheduling meetings. Ensurecurrent schedule is maintained, accurate, and up to date.

· Be responsible for compiling, maintaining andreviewing all necessary reports

· Assist, plan and implement continuousimprovement ideas / opportunities

· Contribute and assist with Corporate, FDA, IMBAuditors and other regulatory bodies during company audits.

· Complete any other duties as requested by SiteManufacturing Management.

Requirements

Basic Requirements:

· Be a results-oriented person with excellentorganizational, communicational and team development skills with an ability tosuccessfully interact with people, create a team environment and generateco-operation

· Demonstrated ability to deliver to team, siteand personal objectives

· Able to successfully manage workload totimelines

· Familiarity with basic project management tools

· Demonstrated understanding and use of RFTtechniques and lean manufacturing concepts

· Strong ability to lead, challenge and positivelyinfluence in an interactive team environment

Basic Qualifications:

· Master's degree or bachelor's degree & 2years of directly related experience OR Associate's degree & 6 years ofdirectly related experience OR High school diploma / GED & 8 years ofdirectly related experience

Preferred Qualifications:

· 2+ years of quality and manufacturing experiencein biotech or pharmaceutical industry

· Bachelor's Degree in a Science Field

· Understanding of the applicablemanufacturing/testing processes (i.e. API, Drug Substance, Drug Product,Packaging, Device manufacturing processes

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