Production -
API (R&D) - Rusan Pharma ltd - Gandhidham
Opening for Manager - Production (API) with Rusan Pharma Ltd (R&D
Center)
Location: Kandla, Gandhidham (Gujarat)
Exp : 5+ Years of Exp from R&D API Background
Profile: Manager Production in R & D
Candidate can apply only if wants to relocate at Gandhidham Location.
Education:
- Masters or PhD qualification in Organic
Chemistry
Job
Description:
Development, Technology transfer and production operation in API.
Expertiseinbuildingteambystreamliningmanufacturingoperationsusingprocedurestofacilitaterobustqualitymanagementsystemswithprocessoptimizationandcontrolrespectingquality,safety
and process norms.
Route scouting, synthesis and scale-up of small organic molecules/intermediate
Plans and schedule synthesis campaigns to support large scale demands
Responsible & audit - the lab documentation in the PRD lab
Innovates solutions to synthetic/scale-up issues (chemical, physical,
preparative, application specific and analytical), transfer results and
involves in scale-up/production
Optimize process flows and methods of concerned working fields.
Plan, evaluate, document and analyse experiments, results and suggest
improvements
Co-operates in cross functional project teams to ensure timely delivery.
Education and supporting of trainees as well as interns and ensure
targeted safe work performance.
Stay up to date with scientific developments in the field of organic
synthesis and organic process research & development percolate the
developments to the peers in PRD lab.
Perform all project work to ensure effective and efficient on budget, on
time delivery of the required amount of product of the required quality.
Carry out practical experiments and demonstrate understanding of organic
chemistry, guided by line manager.
Use literature search engines to aid in selection of work plan with line
manager.
Aid in the development of processes that are suitable and robust to
transfer to pilot plant/kilo lab within budget and to the schedule assigned for
that project.
Identify problems and propose potential solutions, with supervision where
appropriate.
Document all experimental work fully and accurately in lab notebook.
Perform and interpret own routine analysis (eg NMR, HPLC, LCMS, KF).
Discuss the need for obtaining further analytical data with line manager.
Act as support chemist for project in kilo lab./pilot plant operations by
ensuring clear communication of expectations of the process to operations or
plant chemist.
Sr.
Management - Quality Assurance - API - Rusan Pharma Ltd, Ankleshwar
Opening for Sr. Management - Corporate Quality Assurance - API
(Ankleshwar)
with Rusan Pharma Ltd
Qualification : M.sc
Exp : 12+ Years - API Background
Location : Ankleshwar (API)
Responsible for managing QA activities such as deviation management,
change management, SOP compliance, batch release, supplier quality assurance,
complaint handling and document review.
Preparation, Review and Maintaining corporate QMS SOPs. (Deviation,
Change control, Audit Management, Complaints, Self Inspection, and document
reviews).
Market complaints - Investigation, CAPA analysis, resolution of
complaints & taking timely corrective action for critical and major
categories.
Managing QA activities such as deviation management, change management,
SOP compliance, batch release, supplier quality assurance, complaint handling
and document review
preparation / review of various protocols and reports such as cleaning
validation, process validation, validation master plan, computerized system
validation, etc
Communication with international corporate colleagues on various
subjects.
Preparing monthly and yearly reports with respect to QA activities and
presenting the same to corporate QA.
Preparation of the site qualification and validation master plan for
current year and tracking the progress plan on quarterly basis.
Preparation and Implementation of internal audit program.
Documentation, Validation & Qualification, Internal & External
Audit, handling Customer Complaints and indepth knowledge of Regulatory
requirements
E-Mail: corporatehr@rusanpharma.com
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