HIRESIGMA · 1 day ago
Packaging Specialist
HIRESIGMA is a company focused on the pharmaceutical industry, and they are seeking a Packaging Specialist to oversee packaging operations. The role involves ensuring compliance with cGMP and FDA regulations, managing packaging processes, and leading a team in a fast-paced environment.
Qualification
Required
Bachelor's degree in pharmaceutical sciences/ electrical/ mechanical / production or related fields of study
5-11 years of experience in packaging, operations, team management
Understanding of cGMP, FDA regulations, and pharmaceutical packaging processes
Experience in SAP system and packaging data analysis tools
Strong problem-solving abilities, attention to detail, and ability to work in a fast-paced, regulated environment
Excellent communication skills, drive, and sense of urgency
Excellent computer skills, specifically Microsoft Office Suite
Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Packaging Practices (cGMP), complying with legal regulations, monitoring the environment
Knowledge of pharmaceutical packaging and related documents
Knowledge and experience writing, revising, and creating cGMP records and SOP's
Experience with quality system compliance
Ability to work effectively both independently and as part of a team
Capable of handling and participating in compliance and regulatory audits at the local and federal levels
Preferred
Preference will be given to candidates with experience in pharmaceutical MDI packaging
Experience in Inhalation products (Metered Dose Inhaler) is a plus