Registered Pharmacist NADC at Parexel in Quakertown, Pennsylvania

Job Description:

Job Purpose:

The Registered Pharmacist will work with local and global networks to ensure legitimacy of products and remain in compliance with regulatory acts and current legislation. This is subject to sanitary interest, ensuring that the quality of the product is preserved while they remain under their control, in compliance with laws, rules, and GxP regulations governing the conduct of business and profession.

Key Accountabilities:

Regulatory Affairs

Ensure compliance with applicable regulations and current legislation.
Cooperate with the Pharmacy Council and Health Authorities.
Represent the company in all technical-scientific aspects within CTSL.
License holder from National Health Regulatory Authority for Logistics operations referred to Medicinal Products (including IMP&/NIMP, Controlled Substances), Medical Devices, Cosmetics, Foods, and Secondary Packaging Materials.
Management of Controlled substances, license application, and reporting to Health Authorities as specified by country specific legislation and regulation.
Keep abreast of regulatory and relevant updates in the regulatory field and provide guidance to the establishment to make the necessary changes.

Quality Management

Ensure compliance with applicable regulations and current legislation.
Cooperate with the Pharmacy Council and Health Authorities.
Represent the company in all technical-scientific aspects within CTSL.
License holder from National Health Regulatory Authority for Logistics operations referred to Medicinal Products (including IMP&/NIMP, Controlled Substances), Medical Devices, Cosmetics, Foods, and Secondary Packaging Materials.
Management of Controlled substances, license application, and reporting to Health Authorities as specified by country specific legislation and regulation.
Keep abreast of regulatory and relevant updates in the regulatory field and provide guidance to the establishment to make the necessary changes.

Support of Packaging, Labeling & Distribution Operations

Ensure quality characteristics of the products subject to sanitary interest, from receipt until delivery to authorized persons, in the destinations indicated by the holder of the products.
Preservation of the risk of contamination and / or damage to the products.
Ensure compliance with Good Storage Practice, Good Distribution Practice.
Overview of storage and distribution of controlled substances. Key holder for locked cabinets for controlled substances storage. Supervises the movement of controlled substances in the respective parexel premise.
Overall responsible for the reconciliation of controlled substances imported, used, and remain for return and destruction, maintains the Controlled Substances Register and performs its submission to health authorities, as applicable.
Supervises the destruction of controlled substances that were acquired under parexel license.
Ensures compliance with Good Manufacturing Practices during Packaging and Labeling processes.
Approve Master Batch Record for production.
Ultimate release of Medicinal products & Medical Devices manufactured / assembled within parexel facilities.
As responsible Registered Pharmacist, the professional must comply with regulatory acts and current legislation which transgression may result in disciplinary sanctions and other penalties established by law in the country.QualificationsSkills:

GMP / GDP / GCP oriented skills
Analytical skills and ability to identify and address issues proactively in a timely manner
Excellent leadership skills
Ability to act as a cross-departmental networker
Willingness to work in a matrix environment and to value the importance of teamwork
Very good interpersonal, verbal and written communication skills including experience in making; presentations at conferences, meetings, training sessions
Self-motivated with a professional attitude
English proficiency (written and oral English)

Knowledge and Experience:

Knowledge of GxP regulations required
Experience of working in a GxP regulated, global environment with focus on GMP and GDP required
GMP / GCP auditing experience
Regulatory Inspection experience
Relevant experience in Quality Management preferred
Experience with certification and release of IMP preferred
Experience with Import & Export of pharmaceutical products preferred

Professional Requirements:

Pharmacist register unlocked with any other company
Pharmacist register up to date with National and local Ministry of Health
Pharmacist register up to date with the local Pharmacy Council

Education:

Bachelor or Master in Pharmacy, as well as registrationEEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status..