QA Specialist II

Hi,

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Job Title                         : QA Specialist II

Type of Employment     : Full Time

Location                         : ICON PLC, INDIA

Responsibilities:

Recognize,  exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

•        As a member of staff,  the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes  adding value to  our business and meeting client needs.

•        The individual  will recognize the importance  of and create  a culture  of  process  improvement  with a focus on streamlining our processes adding value to our business and meeting client needs

•        Conduct or lead project specific and internal (process I system) audits

•        External (client) audits and Supplier Audits

•        Develops Audit Records and Reports

•        Conduct QA review of SOPs

•        Updates and trains employees in regulatory compliance

•        Review  and  approval  of  Systems   Development   Life   Cycle  (SDLC)   documentation   to   assure regulatory compliance

•        Assesses system related procedures for data collection relative to study protocol

•        Reviews documentation with respect to study protocol and applicable procedures

•        Serve in Inspection Coordinator Role providing timely response to management and clients

•        Provides periodic reports as needed to Quality Assurance Management

•        Willingness and ability to travel for off-site activities as needed

•        Conduct special projects I tasks as assigned (i.e. process improvement,  trends analysis etc.)

•        Travel (approximately 10%) domestic and/or international

•        May be called upon to oversee other QA personnel when acting as a lead auditor or leading a process improvement project or initiative

Experience Skill and knowledge requirement:

To  perform   this  job   successfully,   an  individual   must   be  able   to  perform  each   essential   duty satisfactorily.  The  requirements listed  below  are  representative  of the  knowledge,  skill,  and/or ability required.  Reasonable accommodations may be made to enable  individuals with disabilities to perform the essential functions.

•        A minimum  of 3 years of quality assurance experience in pharmaceutical,  biotech or CRO fields.

•        Able to work with teams and independently .

•        Strong auditing  experience

•        Working  knowledge  of current GCPs  (GLP/GMP may be considered with other experience), Working  knowledge of 21 CFR Part 11  and auditing against the regulation

•        Working knowledge of SDLC  methodology and ability  to audit  systems  against  the methodology and applicable regulations

•        Must possess  excellent  project management skills

•        Excellent   computer, documentation and communication skills are required

•        Due to the nature of this position it may be required for the employee  to travel. 

Therefore, dependent on the employees· location, the employee  may be required to possess  a valid Drivers' license.

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017. 

If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com.

PROCESS

Technical and competency selection:

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

Interview

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

Offer

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.