Sr. Compliance Consultant – Investigations - (REF7336O) - #19504050
Propharma Group, Inc.
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
The duration for this role is 6 months
- CAPA/Deviation Investigation Closure.
- QA Investigations
- Compliance investigator to perform investigations on manufacturing deviations.
- Conduct and write-up deviations investigations in a pharmaceutical facility.
- Responsible for the resolution of deviations, CAPAs, or other documents in order to meet production and product release requirements.
- Utilize root cause analysis techniques during deviation investigational process.
- Work cross-functionally, to support the development and implementation of continuous process improvements
- Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
- Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress
- BS/MS in science major or extensive equivalent experience
- Written investigation experience
- CAPA experience
- Preferred experience with filling operations, solution prep, and fill/finish/formulation
- General knowledge of quality system elements and cGMP regulations.
- Good knowledge of Quality Assurance / Compliance, FDA regulations.
- Experience providing support to clients with quality issues such as OOS results, deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.
- Ability to write and revise Standard Operating Procedures.
- Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
- Carry out duties and responsibilities with limited supervision.
- Flexibility to work occasional weekends and evenings.
- Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
- Ability to plan and manage own work
- Proficient in Microsoft Word, Excel, PowerPoint and Project.
- Must be willing to travel regionally and/or nationally throughout the US.
All candidates must be legally eligible to work in the USA.
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*