PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
Currently, for our Office/Depot in Moscow, Russia, we are looking for a (Senior) Compliance Specialist to join our team
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
(Senior) Compliance Specialist – Moscow, Russia
The role of a (Senior) Compliance Specialist is to provide quality expertise, together with local and global teams in areas such as, warehouse/depot compliance, receipt (incoming goods) control, batch record review, global project involvement, root cause analysis, corrective action/preventive action.
Performance of internal and/or vendor audits, participation in client or regulatory audits, required documentation review/approval, tracking of investigations, deviations or audit responses, the management of corrective and preventive (CAPA) action plans that result, and attendance at inter-departmental meetings related to the area of expertise.
- Supports and executes compliance strategies and initiatives across PPD
- Work as part of a global team and will be an integral member of a team managing PPD owned depots/warehouses
- Ensures compliance with PPD Standard Operating Procedures (SOP), Good Manufacturing/Distribution/Documentation Practices (GxP), industry standards and local regulations
- Qualification oversight, review and approval of qualification documentation for all depots
- Routine spot-checks of processes and depot
- Conducts regular self-inspections of local depot
- Provides support to the department with incoming material inspection as per GMP requirements. Verifies accuracy of receipts performs rigorous documentation checks
- Handles production pre and post line clearances and in-process checks as per GMP requirements
- Reviews batch records and associated documentation for completeness and accuracy of data – prepares documentation for release
- Verifies accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services
- Utilises department checklists to evaluate content of reports and compliance with reporting criteria
- Participates in risk assessments
- Manages set up and filing of documents for global projects
- Generates and updates quality documents (including Quality Agreements, Project Specific documents describing quality role)
- Serves as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews manufacturing investigations, lab investigations, root cause analysis, batch record review or Total Quality Management
- Participates in client and regulatory inspections/audits, might represent the department, and participates in developing and tracking corrective actions
- Works in numerous electronic systems (inventory system, system for handling deviations, CAPAs, effectiveness checks and change controls, finance, regulatory systems)
Experience and Qualifications:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification in a scientific field
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).
- Identified expertise in one or more specialized areas relevant to QA activities, e.g. batch record review, root cause analysis, TQM
- May require knowledge of QP Release activities
- Thorough knowledge and understanding of GxP and appropriate regional regulations and guidelines
- Working knowledge of project based or internal GxP audits and vendor audits
- Excellent English, oral and written communication skills
- Strong problem solving, risk assessment and impact analysis abilities
- Experience in root cause analysis and CAPA management
- Ability to remain flexible and prioritize competing demands/workload
- Solid organizational and time-management skills
- Strong attention to detail
- Ability to work independently as required
- Strong computer skills; ability to learn and become proficient with appropriate software
- Proven flexibility and adaptability
What we offer
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative and friendly environment, with teams of colleagues eager to share expertise and have fun together. We offer global exposure and opportunity to work on international assignments. We are a global organisation but with a local feel.
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD-
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, colour, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.-MG1G1