QA Specialist Deputy RP

The QA Specialist/Deputy RP is responsible for the implementation maintenance and continuous improvement of the quality management system in the pharmaceutical field including the necessary documentation and records in order to ensure and demonstrate that the provisions of the GDP Guide are complied with and the public service obligations for pharmaceuticals medical devices combined medicaldevice products are met and biological products.

Management of authorized activities accuracy and quality of records.

Obtaining and maintaining all permits necessary to conduct business in accordance with corporate governmental and local regulations and requirements.

Responsibilities and Attributions

• Responsible for compliance with all local and corporate legal provisions applicable to the activities carried out
• Responsible for obtaining maintaining and complying with the provisions of the distribution authorisation;
• Responsible for the implementation maintenance and improvement of the quality system;
• Responsible for the performance of public service obligations;
• Offer support and ensure compliance in terms of GDP to diversify the product portfolio.
• Responsible for the quality of products released and placed on the market;
• Responsible for making all records of the distribution of medicines;
• Responsible for compliance with the reporting deadlines to the competent authorities in accordance with the applicable legal provisions and the correctness of the reported data; Maintains the confidentiality of the data and information to which it has access.
• Ensure the development of effective quality procedures and/or processes within the interdisciplinary teams in the group to ensure compliance as well as efficiency in all our quality systems.
• Evaluate quality indicators performance data; communicate compliance status to affiliates as well as risk while maintaining a goal of continuous improvement.
• Ensure that SMC is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; accountability processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented and its effectiveness is monitored).
• Responsible for the management of authorized activities and for the accuracy and quality of records.
• Ensure that initial and continuing training program are implemented and maintained.
• Responsible for the coordination and prompt execution of any drug withdrawal operations.
• Responsible for that relevant customer complaints and ensuring that they are dealt with effectively.
• Responsible for qualification and approval of suppliers and customers
• Approve subcontracted activities that may have an impact on GDP
• It shall ensure that selfinspections are carried out at appropriate and regular intervals following a preestablished schedule and that the necessary corrective measures are implemented.
• Keep appropriate records of any delegated duties.
• Decide on the final disposition of returned rejected recalled or counterfeit products.
• Approve return to stock following internal quality assessment.
• Responsible for the additional requirements imposed on certain products by national legislation are complied with.
• Ensure compliance with the requirements according to the requirements of national legislation on the wholesale distribution license.
• Responsible for inspection of incoming goods and release to the local market.
• Responsible for ensuring that sample management is carried out in accordance with GDP rules and that all local requirements including relevant training of sales representatives are complied with.
• Coordinate the change control process to ensure that changes do not introduce a negative impact on the activity.

Qualifications :

Qualifications:

• University Degree in Pharmacy 
• 3 years of experience in quality assurance quality supervision or relevant experience.
• Technical knowledge in as many of the following areas as possible: quality regulation process sciences production operations.
• Knowledge and familiarity with the product process and requirements of both internal and external customers.
• Comprehensive knowledge of national and EU legislation on GDP
• Knowledge of GxP quality systems and compliance requirements including regulations and standards affecting devices biologics and pharmaceuticals.
• Experience of working both in a team and independently. It works well with the managers guidance to meet tactical objectives while being able to manage his own time effectively.
• Strong oral and written communication skills.
• Knowledge of English.
• Excellent interpersonal skills.
• Strong computer knowledge

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

US & Puerto Rico only to learn more visit ;

US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more: