Multiple Scientific Positions

2 weeks ago

Plainsboro, United States SATHRAM CORPORATION Full time

SATHRAM CORPORATION Seeks:

Validation Engineer w/master’s in Comp Sic, Engg (any), Tech, Cybersecur, Chemistry, Any Analyt Sci or rltd to Anal validation data, prep reps including prep of standard operating procedures by adhering to FDA, cGMP standards. Dvlp and exec of Val plans (VP), Val Protocols (IQ, OQ & PQ), GxP assessment, req Traceability Matrix (RTM) & summary rprts (Validation summary reports VSR) and dvlp Standard Operating Procedures (SOPs). Perf GAP Anlys, Remediation Plan & maintenance of hybrid sys, close & open record sys in cleaning validation.

Clinical Trial Lead w/master’s in Biological Sci, Any Analyt Sci, Tech (any) or rltd & 1 yr of exp to work collab with Clinical Scientist, Clinical Indication/Dvlpmt Lead, & clinical study team to ensure ongoing rev of patient profiles & data listings. Participates in the dvlpmt & rev of dept SOPs & process impr initiatives. Resp for the completeness of docs mng’d in the electronic Trial Master Files (TMF); perf ongoing revs of TMF to assure qlty of the doc files & compl with SOPs, GCP & ICH Guidelines. Supp CPMs with var study start-up activities incl tracking investigator site feasibility status, essential docs rev for the site initiation & investigational product release & enroll. Mng monitoring oversight of site-level activities related to ongoing & planned trials. Dev & mng detailed strategies & docs & provides regular study status updates to senior mgmt. Effectively mngs third-party suppliers for contracted deliverables within qlty, cost, and timeline parameters. Prvds coaching/mentoring to assg program & site staff (CRAs, & CRCs) by demonstrating leadership competencies.

Validation Analyst w/bachelor’s in Engg (any), Micro bio, Tech or rltd & 2 yrs of exp to exec validation plans, req specifications & val protocols incl installation, operation & perf qualification (IOPQ). Prepare or revise val protocols/procedures as reqd. Ensures that all regulatory & cGMPs compliance items rltd to val are satisfied & ensures Val Master Plan (VMP) adherence. Drafting, reviewing, receipt and addressing of comments to appr val docs in compl with FDA & company guidelines. Rev & appr manuf operational use SOPs that apply to validated equipment & processes. Anlys of study data using statistical/analytical sof sys to present in summary reports & with cross functional teams to determine.

Work location is Plainsboro, NJ w/ req’d to travel & work from var unanticipated client worksites throughout the USA. mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail: hari@sathramcorp.com

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