Quality Assurance Compliance Specialist

3 days ago

Pune, Maharashtra, India Instem Full time ₹ 5,00,000 - ₹ 12,00,000 per year

Quality Assurance Compliance Specialist

Location: Pune-Hybrid working-Twice a week in the office

Status: Permanent, Full Time

Package:Competitive Salary (fixed), 5 Day Working Week, Flexible Working (with one-off allowance), Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme.

Why are we hiring a Quality Assurance Compliance Specialist? Were on the hunt for a Quality Assurance Compliance Specialist as part of our companys growth.

The Quality Assurance Compliance Specialist provides day-to-day support for Quality Assurance and Information Security Management teams and other activities as required within the Governance, Risk Management and Compliance group (GRC), to help ensure our quality and information security objectives are met at all sites and to allow the business to reliably manage governance, identify and manage risks and provide independent oversight to ensure the business remains compliant accordingly.

Whos Instem? Well, were a global provider of bespoke industry-leading software solutions and services, which facilitate the pre-clinical, and clinical phases of the drug discovery process. We have over fifteen products in our portfolio, used by over 700 pharmaceutical clients (including all the top 20)

Instem is a unique, solutions-based organisation. Our 5-year growth plan is progressive, and we need you to help us reach that next level

Whats the culture/environment like? For a global business of over 300 staff, we very much have a family feel. Youll be part of a friendly, communal, solution based, flexible environment, where youll feel empowered, valued and accountable. Well invest in you as a person and encourage you to take part in companywide workshops for wellbeing, mental health, critical conversations, and strengths.

What are you responsible for?

  • Planning and executing Internal Process Audits
  • Execute Software Release Audits
  • Supplier Assessment/Qualification/Performance Reviews (quality aspects)
  • Review, authoring and modifying and preparing for publication management system documents
  • Logging/tracking corrective action updates
  • Adherence to the Companys Quality and Information Security Management Systems to ensure that all work is handled Securely, Professionally and Diligently

To be successful in this role, you will need:

  • Certified lead auditor for ISO 9001
  • Skilled at building good working relations with auditees and their managers
  • Sound planning and coordination skills
  • Broad knowledge of Instems products and services
  • Broad technical understanding of software development lifecycle
  • Knowledge of Quality Management and Information Security Management and its application to tasks associated with this role
  • Conversant with GxP such as 21 CFR Part 58 and ERES such as 21 CFR Part 11

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