Governance, Risk and Compliance (GRC) Immediate Start

Skill Required:

Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description).
Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology
Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits
Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402
Strong knowledge of Qualification and Validation project development/implementation processes.
Excellent FDA GxP understanding.
Knowledge of SoX, cGMPs, FDA and EMA guidelines.
Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000
Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance
Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must.
Good Program/Project management skills along analytics & reporting skills with strong communication & presentation.
Ability to work with all level of clients & internal resources
Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred.
Job Description:

Create & Document the control compliance plans for all services in scope
Lead Compliance processes for large Pharmaceutical Client for specific geography
Manages the infrastructure Qualification of hardware/Servers.
Maintains categorization of Off-the-shelf validation categories.
Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services
Develop & Plan internal audit calendar aligned to client’s internal as well as external audit schedule
Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances
Provide agreed upon and ad-hoc reports for audits & compliance operations.
Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits
Conduct process audits for ITSM as per agreed upon process controls
Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines
Remarks/Notes:

We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements