Temporary Validation Specialist (21-00199)
Job Description
“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”
Job Description: Pharmaceutical External Manufacturing Americas – Quality Operations
Provides support of packaging validation, Quality Assurance oversight and Product Release functionality for drug products manufactured by the Contract Manufacturer. Primary responsibility is to support packaging validation activities to ensure that Client products packaged by Contract Manufacturer are operating in compliance with all *** Co. and applicable FDA and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with *** Co. internal and government (FDA or specific market) requirements and support Quality Systems processes.
• Support packaging tech transfer
• Provide reviews and approvals for validation/transfer protocols, reports, and other related documents
• Review and approve change requests
• Investigate and/or evaluate manufacturing and laboratory deviations or incidents.
• Determines disposition of drug products according to Client and regulatory specifications and standards
• Write, review and implement SOPs to ensure compliance with current Client standard and cGMP.
• Supports product recalls and executes plan as assigned
• Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate Client and FDA and EMA agency cGMP regulations and policies.
• Represent Quality on cross-functional teams within the project team
Requirements:
• Experienced with serialization for global markets
• Knowledge in solid dosage forms
• Knowledge of compendia and cGMP requirements, FDA regulations and the ability to interpret and apply them.
• Proficiency with the use of global systems (e.g., TrackWise, SAP).
• Excellent verbal and written communication skills in Spanish and English
• Excellent interpersonal skills.
• Capable to manage multiple priorities.
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
• Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.
• B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy
• A minimum of 7 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience.
• Experience in a Quality Assurance or Quality Control function is required.
• Experience in packaging of drug product is desired.
How to Apply
Please send your updated resume to iris.chen@axelon.com267 total views, 0 today