Senior Specialist QA

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 QA-Audit


 Job Purpose

Support the management of global internal and external audits across PharmaLex in a way that demonstrates compliance with the company's audit policies and procedures, business needs and applicable global legislation and regulations.  Work cross functionally with the VDCs in relation to internal audit, external audits and inspections. Support the Director PLX Global QA Audit Operations and cross cover for other QA or Affiliate audit Team members if required.

Your Job

• Interface with VDCs to agree schedule and timing of audits.
• Manage the audit metrics and report to senior leadership across the business.
• Support the optimisation and continuous development of the audit process in collaboration with the VDC Teams.
• Set up the audit collaboration platform and ensure documentation is available on the platform against agreed timelines.
• Support the backroom Team during audits.
• Ensure easy access and retrieval of audit documentation for stakeholders e.g. SharePoint eQMS.
• Support the development of the audit module in Master Control.
• Assist with drafting of CAPA arising from audits and inspections and ensure the effectiveness of same.
• For internal audit (where applicable):
  • Support the development of the internal audit schedule in collaboration with the VDC Teams.
  • Execute internal audit conduct against the agreed plan.
  • Prepare internal audit reports in a timely fashion.
• For external audits (where applicable):
  • Represent the QA function at external audits.
• For ISO Support (where applicable):
  • Support the ISO9001 certification, for example, internal audits to prepare for certification.
• Key Decisions made by Role
  • Quality related decisions on audits and inspection e.g., effectiveness of CAPAs, risk-based approaches.
  • Reporting and escalation of issues to line leadership.
• The employee agrees to take over other reasonable tasks within the Audit Operations function that are aligned with the abilities and job family.

Your Profile

• Autonomous, concentrated and high-quality work
• Ability to work in a team
• Sense of responsibility
• Very good command of English
• Minimum of 3 years in Quality Assurance with specific experience in auditing and handling of regulatory inspections
• Lead auditor training preferable
• Bachelor's degree in a scientific discipline preferred
• Organizational skills and structured thinking
• Good report writing skills
• Good communication skills and ability to work in a Team and cross functionally with the VDCs and other business partners
• Knowledge of pertinent legislation / regulatory framework and ISO 9001 requirements in respect of audits and inspections
• Results driven
• Experience working remotely within global team setup

We offer

• Opportunity to conquer exciting and varied challenges alongside a talented team
• Flexible hybrid working setup to strike Work Life Balance
• Open and collaborative organizational culture with an emphasis on knowledge-sharing
• 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:

Ms Mayuri Lad
Global Talent Acquisition- APAC Region
 

Agencies only by prior agreement for the specific job opportunity.