Officer-Packaging-OSD -Regulatory - Roorkee @ Jubilant Life Sciences

Job Context:

To effectively monitor production process, meeting regulatory requirements utilizing the technical expertise on machine operation its maintenance.

Challenges:

• Judicious monitoring of machines and equipments.
• Real time reporting of any variance noticed

3. SCOPE SIZE OF THE ROLE:

(Please indicate key metrics defining the size scope of the role)

Revenue / Operating Budget :

Geographical Responsibilities : (Global / International / Country / Area within country)

Roorkee Plant

Area of Impact : (Dept. Location / Function or Business / Organisation)

Roorkee Plant

4. KEY ACCOUNTABILITIES

Accountabilities

Scope of work

• Batch Processing

• Batch processing and execution as per BPR

• Preventive Maintenance

• Planning and execution of the preventive maintenance of the equipments in coordination with engineering department

• Employee Training Development

• Imparting on the job training and demonstration to employees
• Allocation of job to subordinates

• Calibration Verification

• Online completion and review of the equipment, batch packing record, environment monitoring, balance verification pressure differential
• Part of team in equipment qualification and validation

• SAP other Softwares

• Online entries in SAP system
• Handling of QMS activities in Trackwise software

• Compliances Audit

• Maintaining the area all time ready for compliance
• Review and comply the internal audit points
• Review and investigate the market complaints and compliance of the preventive measures to avoid the future complaints

• Waste Management

• Monitoring and controlling the yield losses during entire process activity
• Process optimization

• Breakdown Maintenance

• Procurement of change parts after reviewing and approving drawings provided by RD

• SOP

• Preparation of standard operating procedures (system related and equipment related)

• Consumable Stock

• Maintain consumable stocks

5. KEY INTERFACES

External Interfaces

Internal Interfaces

-

• Men Material
• Equipments Machineries

6. EDUCATION EXPERIENCE

Education Qualification (Highest) with target Institution(s) :

B.Pharm/M. Pharma

Desired Certifications :

-

Experience Range :

2-7 years

No. of years post Highest Qualification :

2-7 years

Desirable Experience :

2-7 years of experience in production area of a pharmaceutical company

7. SKILLS REQUIRED

Skills

Description

Proficiency Level

( General Awareness; Working Knowledge; Functional Expert; Mastery )

Functional Skills :

• Handling of production equipment
• Documentation capabilities like filling of BMR / BPR etc.
• Knowledge of basic cGMP Handling of production equipment

Working Knowledge

Behavioral Skills :

• Good Interpersonal Skills
• Ability to work in a diverse team
• Good Communication skills

Working Knowledge

• General Awareness : Knows the fundamental or general understanding of concepts.
• Working Knowledge : Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concepts in day to day practices.
• Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
• Mastery: Candidate is subject matter expert and has command over the subject/ concepts.