Quality Assurance Executive Qms

6 months ago

Ahmedabad Gujarat, India Nexus pharmachem Pvt Ltd Full time

Job Responsibility

Knowledge Required

OOS, OOT

Deviation

Incident

Change Control

Process Validation

Cleaning Validation

Site master file

Drug Master File
- Responsible for the quality assurance of the batches manufactured
- Responsible for identifying the training requirements of the manufacturing and maintenance personnel and
- imparting the required training.
- Responsible for technical review during new supplier registration and coordinating the inspection of purchased
- Responsible for Calibration/Validation activity.
- Responsible for guiding the Q.C. personnel in attending to Q.C. related problem
- Responsible for batch release.
- Authorized for carrying out corrective and preventive actions.
- Experience in developing, reviewing and approving cGMP and ISO related documents (SOPs, protocols, reports, etc)
- To complete the sample request from different customer which include sample preparation, documentation, COA preparation, packing and dispatch of free sample to the customer and maintain all the required and supporting document.
- To cater and address different Vendor Qualification Documentation requirement like VQ questionnaire, quality agreements, declaration of regulatory compliance documents against the request came from different customer.
- Provide technical support to cleaning activities associated with the manufacturing process.
- Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.
- Supports the periodic review of cleaning validation studies.
- Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
- Checking the quality of incoming and returned materials and component as per specification.
- Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management
- Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
- Ensure accurate and timely completion of all quality-related documentation. Product Quality Control
- Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
- Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Making decisions on batch disposition and product recall based on root cause identification.
- Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.
- Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.
- Timely completion of APQR related activity
- Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,)
- Handling of Market Complaint and Related Compliance
- Handling of out of specification and suitable investigation
- Handling of Deviation and Incident
- Prepared BMR, SOP, Protocols etc.
- Compliance of Vendor Audit, Regulatory Audit etc.

Role: QA Executive

Industry Type: PharmaceuticalAPI

Department: Quality Assurance

Employment Type: Full Time, Permanent

Role Category: Quality Assurance

**Education**

UG: B.Sc / B. Pharm

PG: M.Sc / M. Pharm

Knowledge of computer competence, including database management

Minimum Experience Required: 1 - 4 Year

CV Required

Contact:
Contact:
9909906884

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

**Salary**: ₹15,000.00 - ₹30,000.00 per month

**Benefits**:

- Leave encashment

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- Maximum: 1 year (preferred)

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