Pharma QC Executive Job at Jubilant Pharma, Apply Online
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.
Jubilant Generics (JGL) is a wholly – owned subsidiary of Jubilant Pharma. JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.
The manufacturing location at Mysore is spread over 69 acres and it’s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and
is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business focusses on B2B model for EU, Canada and emerging markets.Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.
JGL’s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.
Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18.
Kindly refer www.jubilantpharma.com for more information about organization.
2. PURPOSE OF THE JOB
Job Context:
To ensure and carry out sampling activities and maintenance of reserve samples. To ensure management of stability studies.
Challenges:
Calibration and Preventive Maintenance of instruments, Preparation of reference / working standards, method development / validation, maintaining cGMP and other compliances in area, correct recording and measuring of results.
3. SCOPE & SIZE OF THE ROLE:
Geographical Responsibilities : (Global/International/Country/Area within country)
Roorkee Plant
Area of Impact : (Dept. Location / Function or Business / Organisation)
Quality Control Lab, Production, Warehouse, Technical Services, Quality Assurance
4. KEY ACCOUNTABILITIES
Accountabilities
Scope of work
Qualification: Qualification & Management of Stability Chambers
Stability Samples:
- Loading & withdrawal of Stability samples
- Storage & destruction of Sample after testing
Reporting:
- Stability report compilation
- To ensure timely analysis of stability samples
- Investigation of deviation, Incidents, OOS & OOT results
Documentation & Recording:
- Storage & destruction of Sample after testing
- Recording of analytical data
- Preparation & Review of SOPs
- Self-auditing
Compliance:
- Adherence of SOPs, STP’s & GTPS
- cGMP / GLP compliance
5. KEY INTERFACES
External Interfaces: Auditors
Internal Interfaces
- Production
- Equipments / Instruments
- Warehouse
- Quality Assurance
6. EDUCATION & EXPERIENCE
Education Qualification (Highest) with target Institution(s) : M.Sc. / B. Pharma / M.Pharm
Experience Range : 3-6 years
No. of years post Highest Qualification : 3-6 years
Desirable Experience :
3-6 years of experience in Quality Control department and handling of all Instruments like HPLC, GC, UV etc. from a regulatory reputed Pharmaceutical unit.
7. SKILLS REQUIRED
Functional Skills :
- Sound exposure to face regulatory audit like MHRA, USFDA, ANVIZA, TGA, MCC etc.
- Understanding of ICH stability guidelines
Functional Expert
- Behavioral Skills :
- Demonstrated ability to work in a collaborative environment with positive interactions and a hands-on approach that emphasizes team work, collaboration, influencing, motivating and consensus.
- Ability to prioritize and deliver on tight timelines
- Proven effective communication skills
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.
Apply for this job here.
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