Executive-Quality Control

Contenido de trabajo

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.Job Description

• DETAILS OF THE JOB

Designation & Job :Officer/ExecutiveLevel :7/8Business Unit :Dosage Forms & APIFunction :Quality Control – IPFPCountry :IndiaWork Location :RoorkeeReporting Manager :Assistant ManagerManager’s Manager :Senior ManagerMatrix Manager :Team Size :07-08Direct Reportees :

• PURPOSE OF THE JOB

Job Context: To analyze the In-Process samples & finished product samples by ensuring compliance & also recording of Analytical data & on line documentation. 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.

• 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 PlantArea of Impact : (Dept. Location / Function or Business / Organisation)Production, Warehouse, Quality Assurance, Technical Services

• KEY ACCOUNTABILITIES

AccountabilitiesScope of work

• Analysis
• To analyse IP/FP samples as per STP with online documentation
• Checking the analytical records and raw data for accuracy in the In process and FP.
• Release of FP
• To ensure timely release of In process / Finished product as per plan.
• Equipment
• Calibration and validation of Instruments and equipments.
• Accident/Incident Investigation
• Ensure investigation of Incidents and OOS and take the corrective steps for further minimization.
• Documentation and Sampling
• To ensure error free documentation.
• To ensure proper arrangements of samples and timely destruction of approved samples after testing.
• Compliances
• To ensure cGMP and GLP compliance and preparation of SOP’s in the work area.
• Ensure good housekeeping in the lab.
• KEY INTERFACES

External InterfacesInternal Interfaces

• Auditors
• Production
• Warehouse
• Quality Assurance
• Technical Services
• EDUCATION & EXPERIENCE

Education Qualification (Highest) with target Institution(s) :M.Sc. (Chemistry) / B.PharmDesired Certifications :Experience Range :3-6 yearsNo. of years post Highest Qualification :3-6 yearsDesirable 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

• SKILLS REQUIRED

SkillsDescriptionProficiency Level(General Awareness; Working Knowledge; Functional Expert; Mastery)Functional Skills :

• Operating and trouble shooting skills on all major analytical equipments like HPLC, GC, UV, etc.
• Good Knowledge of Regulatory guidelines like MHRA, MCC, ANVISA, USFDA, TGA etc.
• Good knowledge of Quality Systems (eg. Market complaint handling, hangling of recalled or returned goods, OOS Investigations, deviations, Change Controls, Quality Management review etc.

Functional ExpertBehavioral Skills :

• Attention to detail
• Data collection, management and analysis
• Problem analysis and problem solving
• Customer service orientation
• Willingness to learn and adapt to changes

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.