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Job Location | Guntur, Bangalore, Kochi, Chennai, Tirupati, Vijayawada, Hyderabad, Vishakhapatnam, Kolkata, Coimbat |
Education | Not Mentioned |
Salary | Rs 3.0 - 7 Lakh/Yr |
Industry | Medical / Healthcare |
Functional Area | Process Control,Pharmacist / Medical Representative |
EmploymentType | Full-time |
Key responsibilities and duties for this position: Formulations:Lead the development of robust, stable and effective formulations (solid oral) to be used for in-house manufacturing and also at 3 rd party manufacturers, when provided the amount of medicinal ingredients in the dosage form for new product development. Comply with GMPs, SOPs and all regulatory documentation. Conduct experimental testing and evaluation of raw materials, dry blends and bulk product. Coordinate formulation and analytical resources as needed, including those provided by production/manufacturing, quality control, quality assurance, supply, regulatory affairs. Prepare manufacturing trial documentation for pilot / small production runs and scale-up operations. Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs in collaboration with the R&D technician. Research and compile raw material documentation for pre-formulation assessment to ensure compliance to testing specifications and regulatory requirements, for new products and existing products whereby and new material is sourced. Work with procurement and finance team to select materials (excipients/ medicinal ingredients) which meet financial goals and contribute to cost saving initiatives. Recommend ingredients / processes which will improve manufacturing efficiencies. Lead technology transfer and scale-up operations to manufacture products in-house. Participate in investigations into product failure including quality, potency, visual characteristics and other. Ensure involvement in all trouble-shooting activities. Develop/review Raw Material and Finished Product Specifications, in collaboration with Product Development Manager and Quality Assurance/ Quality Control Dept. Initiate stability testing (accelerated/on-going) of new products and review/report results in collaboration with Product Development Manager and Quality Assurance/ Quality Control Dept.Reports/Planning:Coordinate with Product Development, Regulatory Affairs, Operations, QC/QA and Supply Departments to ensure that projects are planned and executed in a timely manner. Report on adherence to schedule and trial status on a weekly basis to Product Development Manager. Write product development reports and analyze results.Miscellaneous:Adhere to Health & Safety Policies and Standard Operating ProceduresEducation:Bachelor Degree in Chemistry, Chemical Engineering, or Pharmaceutical Sciences (or equivalent degree in a science discipline) Knowledge of Health Canadas Regulations and Quality Guidelines to formulate compliant products, including those products categorized as Natural and Non-Prescription Health Products.Required Skills/Abilities:Proficient PC Skills: Word, Excel; knowledge of SAP software an assetJob Related Skills:Ability to communicate with multiple departments within the organizations Strong ability to coordinate multiple projects and priorities and work well under time constraints.Technical ability to work closely with manufacturing personnel and trouble-shoot as requiredSpecific Skills and/or Competencies:Excellent verbal and written communication skills Strong interpersonal skills with the ability to communicate effectively with multiple levels within the organization. Must be flexible, a strong team player, excellent attention to detail and have a hands-on approach. Ability to prioritize, organize work load and manage time successfully Ability to problem-solve and resolve conflict Creativity & innovation Analytical skills identify opportunities & leverage synergies
Keyskills :
cost savingraw materialsquality controlstrong interpersonal skillsstandard operating procedurestechnical abilitycontinuous improvement facilitationproduct developmentinterpersonal skillsregulatory affairswritten communicationnatural health prod