About the company
Baxter one of the top Pharmaceutical and medical devices company, with the head quarters located in Illinois. Primary focus of treatment for the company is in the area of Hemophilia and in treating the immune and chronic medical conditions. The firm relieves the issues for millions of patients across the globe serving to the man kind from more than 85 years.
In the year 2018 Baxter was awarded for the best place to work globally. The company have the portfolio of medicines in Critical care, Nutritional, renal care, surgical and Hospital care. Apart from the pharmaceutical medicines the company also provides medical devices and infusions.
About the Job
Research Associate I, - QA
Location of the Job: Ahmedabad
Experience : 8- 10 years with post graduation
Required to have well versed with QP, IQ, OQ, PQ and DQ
Able to write the scripts for qualification if required.
To be a part of CSV team for supporting IT
Ought to have solid abilities concerning composing, looking into and endorsing GMP reports like conventions, tests, Sop's.
Ought to be knowledgeable with Quality necessities like NCR and CAPA the executives with examinations and main driver investigation information, Change The board (would be a benefit in the event that realizes Trackwise device).
Ought to have the option to deal with the group as well as merchants and partners
Solid mindfulness and experience expected in GMP, Gross domestic product, DI, GLP ( GxP), 21 CFR section 11 consistence.
Ought to know about overseeing Undertakings.
Solid cooperative person, relational, delicate abilities, correspondence and hierarchical abilities required.
Ought to know MS-Office instruments, Track wise, Blue Mountain (or comparable adjustment programming stage)
Ought to have critical thinking capacities and arrangements based approach.
Ought to have the option to consider out put away and accompany choices while taking care of any issues.
Ought to have great systems administration abilities (with own colleagues, sellers and cross practical groups ).
Ought to have the option to confront and be the front face in the reviews - interior and outer.
Ought to have the option to recognize the issues and holes and work towards consistent improvement.
Sr. Specialist, R&D - PMT
To circle back to Project Supervisory group (PM-1) for opportune accessibility of licenses (NOC, F29, F11) at the CMO site (in the event of Homegrown Site).
To circle back to obtaining group to guarantee opportune accessibility of RLD expected to begin new item improvement.
To guarantee smooth execution of undertaking by following significant exercises of venture on customary premise and work intimately with cross useful group to assist basic exercises to meet task target timetables.
To guarantee opportune GRN/QC Testing/Arrival of Programming interface/PPMs and fruitful technique move at inner Baxter locales/CMO site for convenient assembling of PE/Strength clumps.
Correspondence of firm PE and Soundness groups dates to different partners at inner Baxter locales/CMO site for smoother activities.
Insinuation for dependability accusing of bunch subtleties to RA for start gathering of dossiers from Baxter Ahmedabad side.
To have a fortnightly conversation in type of a conventional gathering with colleagues for keeping a track on progress of undertaking. Flow of Mother in something like 24 hours of the gathering with focuses talked about, Responsibility and Timetables.
Work with to determine basic issues and clashes of task and raise to higher administration as and when required.
Update the task plan and course gannt outlines fortnightly to higher administration for audit/conversation.
Predict takes a chance in projects and keep up with risk register(by examining with CFT) which likewise incorporates its likelihood and effect and have moderation intends to stay away from defer in project timetables.
Get ready introductions expected for senior administration audit which contain generally speaking status of NPD projects pipeline and yearly recording and endorsement target plan, financial plan consumed and other related data. as mentioned.
Planning dashboard of NPD projects generally outline for senior administration audit.
To get ready show for month to month survey meeting which catches current status, significant open things, basic way and impending achievements of activities by conversation with all partners.
To refresh the worldwide data set consistently for any new filings or geo-extensions in view of any expansion or erasure.
Planning dashboard of Tech Move projects generally synopsis for senior administration audit
To plan Show (Tech Move) for month to month audit meeting which catches current
Item wise/Task wise wellbeing check up and wellbeing survey for In house Research and development Ventures, Remediation Activities and Tech Move undertakings to be ready/Checked/Get approved
Sr. Specialist - CSV
Experience : 10- 15 years
Knowledgeable with administrative rules, for example, 21 CFR Section 11, EU Addition 11, PIC/S and WHO
Knowledgeable with standards of Information Trustworthiness and ALCOA++
Great comprehension of GAMP5 rule and programming classifications
Experience in mechanized framework approval and foundation capability
Experience in Checking on and Approving PC Frameworks in consistence with 21 CFR Section 11 and Annex11 and other administrative rules
Should be knowledgeable in readiness and survey of Approval Conventions intelligence level/OQ/PQ documentation, VP, VSR, SOPs, Convention Deviation, Hazard Evaluation, Decommission report, Occasional Audit Report
Experience in checking on all SDLC records, conventions and SOP's to guarantee they meet administrative direction
Experienced in Creating and evaluating Client Prerequisite Determinations, Practical Necessities Detail FRS and Necessity Detectability Network RTM Archives
Working information on GLP, GCP, GMP, GAMP V rules particularly in the space of PC or related frameworks
Information on Investigating records like (IRA, URS, VP, TP, FRS, DRS, FRA, level of intelligence, OQ, PQ, RTM, change control and deviation
Information on execution of intelligence level, OQ and PQ experiments
Experience on planning of approval expectations like VP, IRA, URS, DS or CS, TP, FRS, FRA, level of intelligence, OQ, PQ, RTM and VSR.
Working information on IT foundation capability, programming approval and Consistence 21 CFR section 11
Information about IAAS, PAAS and SAAS cloud framework