The role of the PA Lead Investigator is integral to the success of the Pharmaceutical Quality Management System in ensuring that Deviations and Complaints (QEs) and resultant Corrective Actions and Preventative Actions (CAPAs) are initiated, investigated, documented and closed out in a timely fashion to prevent recurrence and to ensure customer satisfaction. The investigation process will involve impact assessment and evaluation of risk.
Responsibilities include but are not limited to:
Conduct investigations into reported incidents in order to:
Assess the impact
Identify immediate actions to be taken to limit the issue
Perform trending to identify if there are recurring issues
Establish the cause(s) and contributory factors using appropriate Root Cause Analysis tools
Identify appropriate CAPA to prevent recurrence
Document investigations in a timely manner ensuring the utilization of the authorized tools and systems as appropriate. Make certain details are captured in a succinct and logical manner that will allow for the investigation to be easily understood by approvers, customers and/or regulators.
Qualifications:
Required Experience / Education:
• High School Diploma (or GED) plus 4 years relevant pharmaceutical experience or
• Associates Degree plus 2 years pharmaceutical experience or
Bachlor's Degree
Required Work Experience:
2 years Industry experience within a pharmaceutical or relevant regulated / healthcare environment
Preferred Experience / Education:
- Experience within a role involving incident investigation, data analysis and narrative report compilation
- Technical writing experience
- Knowledge of root cause analysis techniques
What can Almac Group offer you?
- Medical, Vision & Dental benefits from the 1st of the month following start date
- 20 days PTO per year, accrued monthly following start date
- 12 holidays per year
- Company paid Long and Short-term disability along with Life Insurance
- 401k company contribution
- Hybrid work available for applicable roles
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.
UK 
Wed, 16 Oct 2024 00:00:00 GMT