pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
 

Senior Specialist, Global Quality Assurance

Location- Noida

Your Job

  • Support Clinical Services department in performing quality assurance activities related to Clinical Trials.
  • Support Global QA department in maintaining Quality & Compliance to PharmaLex QMS and regulations. Support Global QA department in developing, maintaining, adhering and evaluation of systems, processes, policies, and procedures that promote compliance.
  • Partner with Clinical Services (CLS) for QA support.
  • Implementing and maintaining QMS procedures, conducting audits, and identifying areas for improvement.
  • Perform and conduct quality assurance related activities related to Clinical Services and monitoring of quality relevant aspects at PharmaLex .
  • Fulfilling quality requirements through planning and actions to ensure data is collected, recorded, and reported in compliance with Good Clinical Practices (GCPs) & Clinical trials are conducted safely and ethically
  • Ensures that all processes contributing to the performance of a clinical trials are conducted in compliance with regulations and PLx quality management system policies and procedures.
  • Review of internal processes, maintaining controls and documentation procedures for functions of Quality Assurance.
  • Perform audits as required by Clients, and in accordance with vendor management.
  • Perform audits and develop monitoring methods to ensure Quality Management System (QMS) is appropriately implemented.
  • Provides support as needed in Clinical trial site assessments
  • Support external/client/vendor/sponsor audits.
  • Support & conduct Clinical Research Organizations evaluations, as needed.
  • Coordination of document management, incident management and change management with the VDC.
  • Liaison and collaboration with the Service Area leadership in delivering on the business needs
  • Ensure appropriate and effective implementation of eQMS system in the region.
  • Implementation of global metrics at CLS and reporting of same to the Global QA team.
  • Provide support to Global QA management in business partnering with assigned service line/departments
  • Other duties and initiatives, as assigned.

Your Profile

  •  Master’s degree or equivalent with a strong emphasis on science or quality management
  • 5+ years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
  • Minimum of 3 years’ experience in quality role.
  •  Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience. Additional experience with other requirements (ISO, etc.) is highly desirable.
  • Understanding of Clinical Operations activities, with a preference for candidates with experience in this space
  • Experience with sponsor/site audits in the region they oversee
  • Experience hosting regulatory authorities and interacting with sponsor/client representatives;:
  • English language skillsExcellent verbal and written communication skills and interpersonal skills, with fluent written and spoken
  • Strong organizational skills, ability to multi-task, attention to detail, self-starter, ability to prioritize.
  • Ability to work in a Team and cross functionally with the VDCs ​and other business partners in the region.
  • Autonomous, concentrated and high-quality work
  • Good analytical and problem solving skills​.
  • Strategic, analytical, and structured thinking
  • Decision making​
  • Sense of responsibility
  • Experience working in remote teams.
  •  Results driven.
  • Physical Requirements: Hybrid Working, Open to work in Global flexible timings, Prolonged periods of sitting at a desk and working on a computer, ability to travel

We offer

  • A collaborative and diverse work environment that values innovation and inclusivity.
  • Opportunity to join a fast paced growing Global MNC and conquer exciting and varied challenges alongside a talented team
  • Ability to work independently and collaborate effectively in a global, cross-cultural environment.
  • Flexible working hours striking a good work life balance
  • Business interaction with nearly all branches of the company across 5 continents
  • A broad range of initiatives for personal development and professional training


If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

 

Agencies only by prior agreement for the specific job opportunity.