Officer Quality Assurance Recruitment 2020 – Jubilant Pharma
Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
Job Title: Officer-Quality Assurance
Level: 7
Business Unit: Dosage Forms
Function: QA – IPQA
Country: India
Work Location: Roorkee
Reporting Manager: Assistant Manager – IPQA
Team Size: 10-15
PURPOSE OF THE JOB
Job Context:
To ensure online entries of BMR & BPR and also to ensure timeline clearance of the same. Responsible for in-process tests, all in compliance with cGMP
Challenges:
Facilitation of Quality, Collaboration, Early Testing, Verification, Timely test Coverage
SCOPE & SIZE OF THE ROLE:
Geographical Responsibilities : (Global/International/Country/Area within country)
Area of Impact : (Dept. Location / Function or Business / Organisation)
KEY ACCOUNTABILITIES
Accountabilities
Scope of work
- SOP
- Responsible for preparation of SOPs of IPQA
- Batch Manufacturing Documents
- Responsible for monitoring and ensuring on line review of batch manufacturing documents, batch packing documents
- Responsible for review of batch manufacturing Packaging and Analytical records, equipment logs, etc. before batch release
In-process Controls - Responsible for carrying out In Process control tests, line clearances activities, sampling during process validations, cleaning validation, batch manufacturing, packing
GMP monitoring - Responsible for monitoring adherence to various cGMP activities and laid down procedures in receipt, storage, testing, processing and dispatch of products
KEY INTERFACES
External Interfaces
Internal Interfaces
- Govt. officials
- Auditors
- Regulatory Bodies
- Production
- Warehouse
- Quality Control
EDUCATION & EXPERIENCE
Education Qualification (Highest) with target Institution(s) :
B Pharma
Desired Certifications :
Experience Range :
1-5 years
Desirable Experience :
2-5 years of Experience in sampling and in-process checks
Functional Skills :
- Good knowledge of in-process checks and QA systems.
- Exposure of regulatory audits like MHRA / USFDA/ ANVISA/ TGA/MCC/WHO
- Knowledge of cGMP
- Functional Expert
Behavioral Skills :
- Good Communications skills
- Problem-solving skills
- Willing to learn new methods and systems
- Sound judgment and decision making
- 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: The candidate is a certified functional expert with strong knowledge on concepts.
Mastery: The candidate is a subject matter expert and has command over the subject/ concepts.
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