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Manager-Quality Assurance
Jubilant Enpro
posted 14hr ago
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Job Description
Introduction:
Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S. Bhartia and Mr. Hari S. Bhartia with strong presence in diverse sectors like Pharmaceuticals, Life Science Ingredients, Contract Research & Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America.
Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses.
In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.
The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Find out more about us at www.jubilantpharmova.com .
The Position
Organization- Jubilant Pharmova Limited
Designation Manager- QA
Location- Nanjangud, Mysore
Key Responsibilities.
- Shall be responsible for quality oversight in Production blocks and shall review process, procedure, facility and training.
- Batch release (or reject) activity for API s manufactured at all Plants. This includes review of BPRs, review of IOCBN, verification and distribution of PAF, review of product label and approved label, retaining control sample and verification, inspection as per the checklist for finished product release to customers and updating of finished product distribution records.
- Review & evaluation of change controls, clean room allocation form, material re-allocation form, reprocess approval form and Packing clearance form and closure of the same before the product release.
- Responsible for visual inspection and line clearance for the product change over activities.
- Perform the cleaning validation samples as per approved protocol.
- Must have knowledge on handling all QMS related activities.
- Shall be responsible to identify the area of improvement and to review the followings:
- To review training records on the particular operations that the employee performs.
- Plant area & pharma room cleaning is performed as per established procedure.
- Equipment status board are updated with current status.
- Availability of current version of SOP for operation and calibration of equipment in the work
- Place & accessible to operating personnel.
- Batch production records are placed in work stations during the entire operations.
- Equipment usage and cleaning log is updated by operating personnel.
- Sampling procedure for in-process & intermediate is followed by operating personnel.
- Weighing balance/measuring instruments used in production are calibrated as per established procedure and records are maintained.
- All the accessories (scoops, samplers, scrapper etc.) are coded and cleaned as per established procedure.
- Online monitoring the recording of batch production record & batch cleaning record to comply the ALCOA.
- Dispensing of intermediates and cleaning of dispensing room performed as per established procedure.
- Intermediates, rejected materials are stored in designated place and temperature & relative humidity is maintained.
- Entry & exit procedure available in the clean room & followed by operating personnel during routine operations.
- Equipment are cleaned within the specified time after use as per established procedure.
- Sampling procedure for cleaning samples during product changeover cleaning is followed by operating personnel.
- Monitoring of process & cleaning validations executing as per approved protocol.
- To coordinate for root cause investigation for product failures & customer complaints.
- Coordination and implementation of CAPA for all audit observations & any non-conformances.
- Communicate with management, production regarding questionable measurements, non-conformance issues.
- Shall be responsible for SAP activities.
- Shall be responsible for lifecycle management activities of production
- Shall be responsible for the track wise activities.
- Shall be responsible for initiation & evaluation of CCF, MRF, PCF, CRF & RPF in track wise and SAP.
Person Profile.
Education Qualification: Post Graduate in Science/ Master of Pharmacy/ Bachelors of Engineering.
Experience Range : 15+years
Employment Type: Full Time, Permanent
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Strict timing
Monday to Friday
No travel
Day Shift
Jubilant Enpro Benefits
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