QA Auditor 1

2 days ago

Noida, India IQVIA Full time

**Company Overview**

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

**Process Overview**

Details about the consulting business

Define and review implementation strategy for Pharmaceutical Companies for various safety management products/services offered by IQVIA.

Assist lead auditors/audit liaisons in conducting, hosting and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QM staff.

Development/refinement of QMS documents.

**Responsibilities**:
Key components of the responsibilities are as mentioned below:

- Quality Coaching - coach employees on regulatory compliance, quality practices (in person, by video conference, WebEx, teleconference) and the Foresight QMS.
- Quality Reviews - perform reviews of project deliverables, training materials, sales proposals, etc.
- Auditing (Internal, External, Facilitation) - prepare documentation for auditor examination, coordinate resources, respond to audit findings (if any), and manage remediation efforts (if any) to closure.
- Development/refinement of QMS documents - Participate in this activity which includes, but is not limited to, Standard Operating Procedures (SOPs), working practices, and business process improvements.
- Follow and guide on the cross-phase procedures and plans like Deviation Management Plan, Change Control Procedure, Document Management Procedure and Training Plan
- Closely work with different key process areas to support implementation and resolve product issues
- Provide QMS training

**Requirements**:
**Mandatory Skills**:

- B.E / B.Tech./ MCA
- 1+ year Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
- Considerable knowledge of GXP regulations and quality assurance auditing techniques.
- Strong interpersonal skills.
- Excellent problem-solving skills.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Ability to prioritize and manage projects and adapt to changes in priority efficiently.
- Excellent interpersonal and people skills.
- Ability to thrive in a fast paced, dynamic environment and operate under stringent
deadlines.

**Desired Skill**:
Knowledge of 21 CFR Part 11, GxP, EU Annex 11,

**Experience Range**:1-3 years

**Work Timings: General Shift (10 AM to 7 PM) IST**

**Job Location: Noida

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