Executive/ Sr. Executive
Job Description:
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Perform Extractables & Leachables (E&L) studies in line with BPOG and regulatory guidelines (USP <1663>, <1664>, ICH Q3D).
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Operate and maintain instruments like LC-MS/MS, GC-MS/MS, UHPLC, GC-FID.
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Conduct method development, optimization, and validation for targeted and non-targeted analysis.
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Interpret mass spectral, elemental, and chromatographic data for accurate reporting.
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Support wet chemistry tests (pH, conductivity, titrations) and documentation activities.
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Prepare/review SOPs and validation reports, ensuring compliance with GLP, NABL, 21 CFR Part 11, and US FDA requirements.
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Experience in Nitrosamines, PFAS, Bisphenol A, and unknown screening is preferred.
Company Profile
Since 1998, APPL is in the business of Silicone Elastomeric products and also, other Polymeric components which ultimately provide solutions to Fluid Transfers, Sealing, and Contamination controls for Biopharma, Pharma, Medical, Laboratory, Food, Beverages, and Engineering sectors worldwide.
APPL is having ISO Class VII and ISO Class VIII Cleanroom facilities certified with ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, ISO 13485:2016. We also have a BPOG extractables program for our products for regulatory markets worldwide.
The company believes in “Be in business with ethics” and assure Quick Development, Fastest Delivery, Ultimate Quality and also very Competitive Rates.
Telephonic Interview Available
- Telephonic interview are scheduled for this job opening.
- Interested Candidates are requested to apply and get recruiter contact number for telephonic interview.
- Candidates can call recruiter on given contact to start telephonic interview during working hours.