SUN PHARMA, one of the world’s largest specialty generic companies, operating in over 150 markets worldwide, has been present in the U.S. since 1996, focusing on generics, branded generics and over-the-counter (OTC) products. We are a vertically integrated company and valued supplier to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers.
This position is located at OHM LABORATORIES Inc., a SUN PHARMA Company; and is one of the nation’s leading manufacturer of OTC pharmaceuticals. A long standing history of superior product and a steadfast reputation for excellence has positioned OHM LABORATORIES Inc., as an integral partner of choice by many leaders in industry. Rigid quality control, quality assurance, versatility, personalized service, and the expertise of our team have continually attributed to the success of OHM LABORATORIES Inc.
Responsibility for preparation of prevalidation and process validation documentation such as CCRs, MBRs, protocols and reports. Preforms characterization, prevalidation and process validation as well as process trouble-shooting, process optimizations and assist in investigations. Assist production shifts to ensure smooth transfer of new products or process enhancements of existing products.
Manufacturing of Process Prevalidation and Validation Batches.
Manufacturing of Exhibit Test Batches, in case of alternate sources.
Preparation of Master Batch Records and maintenance in current status.
Preparation of SOPs related to Manufacturing Science & Technology Group (MSTG) and maintenance in current status.
Preparation of Process Validation Protocols and Reports as a back up to Validation Associates.
Troubleshooting and preparation of Corrective and Preventative action plans.
Compliance with all cGMPs.
Other responsibilities may be assigned as deemed necessary.
Bachelor of Science (B.S.) in Chemical Engineering, Pharmaceutical Sciences, Physical or Life Sciences.
Three (3) to Six (6) years of experience in process validation of solid (oral) dosage forms within a cGMP pharmaceutical environment (preferably at generic company).
Ability to perform mathematical calculations, operations and basic statistics.
Ability to perform an investigation and derive corrective and preventative action plans using scientific reasoning.
High proficiency in MS Office applications (Word, Excel).
Strong attention to detail and highly organized.
Must be a self-motivated and proactive team member with positive interaction with colleagues and stakeholders to ensure teamwork, work ethics and discipline.
Ability to coordinate and prioritize work in an effective and efficient manner.
Manage with quality multiple projects and tight timelines.
Must have excellent interpersonal and communication skills (verbal and written).
Conduct oneself in a professional manner in alignment with corporate values.
Ability to work and interact successfully in a global, diverse and dynamic environment.