Senior Contract

3 weeks ago

Dublin, Dublin City, Ireland 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 Title: Senior Contract & Development Manager

Job Summary:

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

· The candidate will have excellent troubleshooting skills using standard industry techniques

· Position will be responsible for managing and executing nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities for the External Supply organization

· Determines situations which require escalation to management

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

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

· Be responsible for compiling, maintaining and reviewing all necessary reports

· Assist, plan and implement continuous improvement ideas / opportunities

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

· Complete any other duties as requested by Site Manufacturing Management.



Requirements

Basic Requirements:

· Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation

· Demonstrated ability to deliver to team, site and personal objectives

· Able to successfully manage workload to timelines

· Familiarity with basic project management tools

· Demonstrated understanding and use of RFT techniques and lean manufacturing concepts

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

· Strong computer skills - knowledge Quality tracking system (QMTS).

Basic Qualifications:

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

Preferred Qualifications:

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

· Bachelor's Degree in a Science Field

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



#LI-PM3

Requirements
Basic Requirements: · Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation · Demonstrated ability to deliver to team, site and personal objectives · Able to successfully manage workload to timelines · Familiarity with basic project management tools · Demonstrated understanding and use of RFT techniques and lean manufacturing concepts · Strong ability to lead, challenge and positively influence in an interactive team environment · Strong computer skills - knowledge Quality tracking system (QMTS). Basic Qualifications: · Master's degree or bachelor's degree & 2 years of directly related experience OR Associate's degree & 6 years of directly related experience OR High school diploma / GED & 8 years of directly related experience Preferred Qualifications: · 2+ years of quality and manufacturing experience in biotech or pharmaceutical industry · Bachelor's Degree in a Science Field · Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes #LI-PM3

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