Quality Assurance

2 weeks ago

Mumbai Maharashtra, India AHRC Pvt Ltd Full time

**Required Qualification**:
1. D- Pharm/ B Pharma/ M Pharma with Hands -On working experience in QA Pharmacist role 2. Mandatory to have Valid Pharmacy License and PPP. 3. Experience : 1-5 years experience Mandatory*

**Responsibilities**:
1. **Preparation, Revision & Training** of QA SOP's: Hands on Experience of SOP Management Preparation & Revision of QA SOP's in Control Document Management System (CDM'S) as per requirement. To conduct Training of approved QA Sop's to all concerned persons.

2. **Audit & Inspection Readiness**: Preparation of Annual Internal Audits schedule. Performing Internal Audits as per approved schedule. Preparation of Internal Audits report. Raised the CAPA's in Track-wise system after agreement with stakeholders. Verification of CAPA's effectiveness after predefined period.

3. **Periodic Product Review**: Preparation of Periodic Product Review (PPR) of the products.

4. **Preparation of Periodic Product Review** (PPR) of the products. To support contract manufacturing sites for validations during product transfer.

5. **Process, Equipment, Facility & Utility Qualification**: To permed change control assessment validation / qualification perspectives. Preparation and Maintenance of Site Validation Master Plan (SVMP). Preparation of Monthly presentation on Site validation Steering Committee. Tracking of monthly re qualification schedule

6.**Cleaning Validation**: Preparation of Cleaning Validation Protocols & Reports. Performing Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) Study.

7. **Quality Management Systems**: To carry out the gap analysis against Quality Management Systems. Handling change controls, deviations and CAPA's. Carry out risk assessment in view of change in process / introduction of new product. Raise and progress departmental change controls, deviations and CAPA'

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

Pay: ₹225,000.00 - ₹360,000.00 per year

**Education**:

- Bachelor's (preferred)

**Experience**:

- SOP Management: 1 year (preferred)
- Control Document Management System: 1 year (preferred)
- Annual Internal Audits: 1 year (preferred)
- CAPA's: 1 year (preferred)
- Periodic Product Review (PPR) o: 1 year (preferred)
- Site Validation Master Plan (SVMP): 1 year (preferred)
- Clean Equipment Hold Time (CEHT): 1 year (preferred)
- Dirty Equipment Hold Time (DEHT): 1 year (preferred)

Work Location: In person

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