Officer - Quality Assurance - Ankleshwar, India - Kaapro Management Solutions
Description
Opening: 2 Nos- Job ID:
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
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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