Description:

　　The Senior GMPQA Compliance Specialist (Consultant) will manage and maintain an efficient and effective Quality System. Incumbent will do this in accordance with cGMP, ICH, FDA and any applicable international, federal and/or local laws and regulations and standard operating procedures.

　　Additional Skills & Qualifications:

　　Complies with internal Quality Systems applicable to MTPA procedures, policies, governances, work instructions, company global quality documents including Global Quality Agreement and Quality Policy, etc.

　　Authors Standard Operating Procedures (SOPs), and Work Instructions (WIN) to maintain compliance with the principles of Current Good Manufacturing Practices (cGMPs), ICH, and other appropriate regulations.

　　Serves as reviewer/approver for: Label Text and Label Proof Approval forms, Links Summary Reports/Variable Data Information, vendor generated packaging Batch Records and supporting documentation that lead to pre-approval and final release of Investigational Product (IP) and Commercial Product

　　Releases Investigational Product (IP) and Commercial Product; Coordinates with approved vendor to achieve approval/release status.

　　Initiates Corrective Action/Preventive Action (CAPA) program for major and critical deviations/incidents, internal/external audit observations, and complaints that are critical to product quality or significantly impact processes. Manage and document CAPA for MTPA Clinical Supplies/GMPQA, clinical supplies packaging vendors, MTPA PQA and commercial vendors.

　　Initiates investigations into Deviations, Incidents and Complaints within the company and with vendors; ensures resolution and close-out; assists management with product/client complaints.

　　Performs GMP Document Control activities such as maintaining deviation, CAPA and complaints logs, vendor and internal audit schedules.

　　Approves internally initiated or vendor requested Change Control to ensure changes that affect GMP systems are evaluated for potential, approved/disapproved, implemented and documented.

　　Maintains the Internal Audit Schedule and perform Internal Audits of quality functions and Clinical Supplies (CSP) systems and procedures for Investigational Product (IP), and supports the commercial Internal Audit program as a member of PQA (Product QA) .

　　Experience Level:

　　Expert Level

　　*Onsite expectation is once a month

　　About Actalent

　　Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

　　If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.