CMIC CMO USA
Overview
ASSOCIATE DIRECTOR - PACKAGING (Cranbury, NJ): develop pharmaceutical packaging planning and scheduling metrics; analyze, develop, and modify packaging requirements to ensure ANDA batches are compliant with cGMP, SOP, FDA, DEA, and OSHA regulations; prepare packaging validation documents, CCRs, PBRs, BOMs, SOPs, protocols, and reports; perform characterization, validation, exhibit batches, and CAPA investigations. Prepare qualification documents (IQ, OQ, PQ) and validation for equipment and control systems; perform gap assessments and root-cause analysis with evaluation of CAPA effectiveness. Salary : $160k. Location: Cranbury, NJ. Foreign deg. OK. Send resume to CMIC CMO USA Corp., 270 Prospect Plains Rd., Cranbury, NJ 08512. Responsibilities
Develop packaging planning/scheduling metrics and analyze packaging requirements for compliance with regulatory standards. Prepare and maintain packaging validation documents, protocols, reports, and related records (CRRs, PBRs, BOMs, SOPs). Conduct characterization, validation, exhibit batches, and CAPA investigations. Prepare qualification documents (IQ, OQ, PQ) and validation for equipment and control systems; conduct gap assessments and root-cause analyses with CAPA effectiveness evaluation. Qualifications
Bachelor’s degree (or equivalent via suitable combination of education/training/experience) in Pharmaceutical Sciences, Pharmacy, Chemistry, or related field. At least 2 years of experience in areas such as CCR, MBR, BOM, SOP, protocol/reports; characterization, validation, optimization, CAPA; packaging of pre-validation/validation batches. Foreign degrees accepted. Location
Cranbury, NJ Seniority level
Mid-Senior level Employment type
Full-time
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ASSOCIATE DIRECTOR - PACKAGING (Cranbury, NJ): develop pharmaceutical packaging planning and scheduling metrics; analyze, develop, and modify packaging requirements to ensure ANDA batches are compliant with cGMP, SOP, FDA, DEA, and OSHA regulations; prepare packaging validation documents, CCRs, PBRs, BOMs, SOPs, protocols, and reports; perform characterization, validation, exhibit batches, and CAPA investigations. Prepare qualification documents (IQ, OQ, PQ) and validation for equipment and control systems; perform gap assessments and root-cause analysis with evaluation of CAPA effectiveness. Salary : $160k. Location: Cranbury, NJ. Foreign deg. OK. Send resume to CMIC CMO USA Corp., 270 Prospect Plains Rd., Cranbury, NJ 08512. Responsibilities
Develop packaging planning/scheduling metrics and analyze packaging requirements for compliance with regulatory standards. Prepare and maintain packaging validation documents, protocols, reports, and related records (CRRs, PBRs, BOMs, SOPs). Conduct characterization, validation, exhibit batches, and CAPA investigations. Prepare qualification documents (IQ, OQ, PQ) and validation for equipment and control systems; conduct gap assessments and root-cause analyses with CAPA effectiveness evaluation. Qualifications
Bachelor’s degree (or equivalent via suitable combination of education/training/experience) in Pharmaceutical Sciences, Pharmacy, Chemistry, or related field. At least 2 years of experience in areas such as CCR, MBR, BOM, SOP, protocol/reports; characterization, validation, optimization, CAPA; packaging of pre-validation/validation batches. Foreign degrees accepted. Location
Cranbury, NJ Seniority level
Mid-Senior level Employment type
Full-time
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