Production – API (R&D) – Rusan Pharma ltd – Gandhidham
Opening for Manager – Production (API) with Rusan Pharma Ltd (R&D Center)
Location: Kandla, Gandhidham (Gujarat)
Experience : 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.
Masters or PhD qualification in Organic Chemistry
- Development, Technology transfer and production operation in API.
- Expertise Building Team Streamlining Manufacturing Operations Using Procedures To Facilitate Robust Quality Management Systems With Processor Imitation And Control Respecting Quality, 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
Experience : 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