QA Validation Specialist

QA Validation Specialist

Vacancy Number:

Location: Lamar Twp

Location Address:
88 Heckmans Gap Rd, Mill Hall
Pennsylvania, PA 17751
United States

Be part of our journey
As a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate and excited about how we can develop and utilize new technologies to shape and inspire changes within an ever-growing market place.

Our ideal person
As a business, it’s really important to us that we find the best person for the job and that you have the best opportunity to succeed in the role. To help, we have outlined our expectations for the role and what core skills and experiences we require as well as what would make you an ideal fit. In turn, we hope this helps you evaluate if this is the right job for you.

• To coordinate implementation of the Site Validation Master Plan for plant, control systems and computer systems validation to support manufacture on site
• Responsibility for the Process Validation program for the site
• Responsibility for the Cleaning Validation program for the site
• Support of Laboratory and Analytical Method validation programs
• Plan, organize and coordinate multiple validation projects on site, both short and long term that will involve coordination with a number of internal and external stakeholders
• Develop and oversee lifecycle management processes for the demonstration of continued compliance
• To support and deputize for the Head of Quality in matters relating to validation
• To coordinate activities with site departments for the purpose of generating data for site regulatory submissions
• To assist with regulators and external customers as required in activities such as site inspections to relay information with regards to validation
• Requires a persuasive, tenacious personality, who can transfer verbal discussion into written communication, through site validation documentation and procedures, ensuring the ensuing systems are implemented and maintained to a high standard and in compliance with quality and validation requirements
• Manage the knowledge flow of validation information to customers in compliance with commercial contracts
• Assistance in generation of Annual Product Quality Reviews
• Prepare annual product quality review reports for site products
• Write/update and review standard operating procedures
• Additional Quality Assurance functions as required

• Degree in relevant scientific discipline or equivalent experience

• Knowledge of cGMP, ICH and FDA 210 + 211 guidelines
• Knowledge and experience of GAMP5
• Knowledge and experience of ISPE guidelines
• 5+ years validation experience in a pharma environment
• Strong working knowledge of validation landscape
• SAP experience preferred; but not required
• Database use and experience

• Must have oral & written proficiency in the English language, internally with all functions on site, externally with suppliers, auditors and customers

• Proficient in MS Office
• Knowledge of electronic QMS systems

• Project Management skills
• Problem solving skills
• Efficient, reliable and competent in self organization skills
• Able to work as a team

• Able to walk, sit, or stand for a minimum of 8 hours per day