Compliance Officer

2 days ago


Ahmedabad Gujarat, India Imaginations Softech Solutions Pvt Ltd Full time

**Qualification**:
 Pharmaceutical/ Scientific degree

 Experience of operating within a Quality Management system

**Profile required**:

- Clear and effective communication English communication skills - both written and oral
- Excellent IT skills with advanced level of MS word & Intermediate Excel
- The ability to analyze data, troubleshoot issues, and find solutions
- Manage time effectively, meet deadlines, and coordinate with crossfunctional

teams
- Understanding regulatory requirements and standards such as ISO 13485

**Responsibilities**:
Monitoring of dedicated technical enquiries helpdesk, responding to

queries and generating appropriate compliance documents in line with the

requests to internal and external stakeholders.

Ensuring Device labelling compliance, approvals, specifications.

Ensuring master labelling specifications are aligned with relevant

legislation

Supplier database management and updates.

Batch Record evaluation for compliance

Bespoke technical and compliance documentation as per customer

requirements

Maintenance of technical drive, ensuring document compliance

Transfer analytical results to company specific documentation

Tracking and logging information for compliance processing

MDR/Technical file compilation support

Complete actions assigned from QMS assigned CAPA, Change Control,

planned deviation, Risk assessment

**Additional guidelines**:

- Working Hours: 9:00 am - 5:30 pm
- Working Days: Monday to Friday
- No Indian holidays
- **Recruitment for our client Day Lewis Plc (UK)
- EM Pharma Division**_

**Job Types**: Full-time, Permanent

Schedule:

- Day shift
- Fixed shift
- Monday to Friday

Work Location: In person


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