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Deputy Manager

Deputy Manager

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Hetero

4 - 6 years

4 - 8 Lacs

Hyderabad Jadcherla

Posted:3 days ago| Platform:

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Skills Required

iso sqlite production android kotlin android studio packaging gmp pmp process validation quality management java mvvm retrofit android application development sop ohsas 18001 safety quality assurance qms management systems json reporting

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for following activities in purification area of BM/BU based on campaign basis

1. Following GMP, safety practices in production facilities and work place.

2. Responsible for production activities:

Execution of area, line clearance before execution of activities.

Execution of product changeover activities.

Responsible for column cleaning, packing, unpacking, evaluation and maintenance.

Responsible for drug substance (FDS) transfer/dispensing.

Execution of production activities.

Monitoring and review of batch parameters/performance.

Ensuring material are arranged properly before activities.

Verification of samples for analysis.

Responsible for shift Monitoring.

Handling of online reject material.

Review of soft copy for batch monitoring and performance.

Execution of process validation.

Execution of cleaning validation.

Execution of verification protocols/equipment specific protocols.

Ensuring buffer preparation in respective shift.

3. Handling of documents:

Preparation of new / revision of SOPs, protocols and reports.

Preparation of MFRs and BMR's.

Primary review of executed BMR's submission to QA.

Ensuring online BMR's updation and review of log books.

4. Responsible for monitoring and operation of following production equipments (but not limited to):

AKTA Process Purification system Conductivity meter

TFF System Peristaltic pumps

Weighing Balance Mixing Systems

Biosafety cabinet Filter integrity tester

pH meter Walk in cold Freezer room

Heat Exchanger Mixing vessels

Ensuring proper data backup of equipments.

Provide clearance for calibration, PMP and validation of equipments.

Participate in execution of equipment validations.

5. Responsible for Quality Management Systems

Initiation / Review of breakdown request.

Initiation of CRN's and Preparation of Risk Assessments.

Initiation of incidents, investigation, CAPA.

6. Team member:

Facility readiness for audits.

7. Training:

Training team members on SOPs / GMP aspects.

Attending training on related SOP's / GMP aspects.

8. Monitoring of PM/Qualification of purification area equipments.

(Calibration / PMP/Qualification).ease enter job description

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Pharmaceuticals

Hyderabad

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Deputy Manager