Officer - Quality Assurance

3 weeks ago

Ankleshwar, India Kaapro Management Solutions Full time

Opening: 2 Nos.- Job ID: 56491- Employment Type: Full Time- Reference:
- Work Experience: 2.0 Year(s) To 7.0 Year(s)- CTC Salary: 3.00 LPA TO 7.00 LPA- Function: Production / Quality / Maintenance- Industry: Pharma/Biotech/Clinical Research- Qualification: B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry- Location:

- Ankleshwar

Posted On: 16th Mar, 2023
**REQUIREMENTS**

**Education / Experience**

**Education**:
Graduate / Post Graduate in Pharmacy or Chemistry

**Experience**:
2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements

**_ JOB PURPOSE_**

**Generic**

Implement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics.

**Specific additions (if needed)**

**KEY ACCOUNTABILITIES**

**Quality **Management/Continuous** Improvement**

Line Clearance and shop floor compliance

Assisting in Complaint Investigation system at site

Assisting in Qualification and validation system, change control system, deviations

Preparing & review the Annual Product Quality Review

Review of Batch Manufacturing & Packing Records

Coordination of cGMP Training activity.

**Compliance**

Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by

Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity **Validations & Qualifications**:
Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes

Review of protocols for qualification and validation of facility/ equipment / product / process

Review of validation reports after execution of validation of facility /equipment / product / process

**Documentation Control**:
Preparation and Review of SOPs

Controlled distribution and archival of documents & record

Control of master documents

**Assuring quality of products by**:
Ensuring SOP compliance

Review of Batch Manufacturing & Packing Records

Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints

Ensuring the effectiveness review of the implemented CAPA

**cGMP Training**:
To prepare training modules and organize training in GMP

Execute the training program in coordination with all concerned departments

**Other**:
Review of maintenance and calibration program

**Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations**

**Key Skills**:

- Qa
- Qms

**Company Profile**:
API - Manufacturing Company in Ankleshwar, Panoli, Dahej & Karkhadi

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