Deputy Director

Group Company

#*Glenmark Speciality SA*#

Designation

#*Responsible Person Deputy*#

Office Location

#*Switzerland*#

Position description

• #*
• The definition of the QRPD refers to the Quality Assurance function in the Glenmark Specialty S.A. organization aligned with the current regulations applicable within the Swiss jurisdiction for enterprises involved in international pharmaceutical trade, encompassing both finished and semi-finished products (I-SMI-TI17).
• *#

Primary Responsibilities

#*

Responsibilities:

Quality Management System

·

Support the QRP in the direct pharmaceutical supervision of GSSA activities.

·

Provide routine support for the proper conduct of medicinal product trading activities and the traceability of purchases and sales.

·

Support the QRP in verifying that suppliers and customers are authorised to perform their respective activities.

·

To perform a formal trade review for every batch by verifying the correctness and authenticity of the supporting documentation.

·

Support the QRP in ensuring that the necessary storage conditions remain within the limits determined by the manufacturer or stated on the packaging during the transportation from the supplier to the customer.

·

Support the maintenance of a communication system that enables the provision to suppliers and customers of all standard and on-demand information relating to the quality and safety of each batch supplied.

·

Support the QRP in supervising and maintaining an effective procedure of batch recall of medicinal products.

·

Support the QRP in maintaining compliance of the trading processes of pharmaceuticals with EU GDP and with the Swiss laws.

·

Support the QRP in ensuring that there is close expert supervision within the company and that safety and product integrity are maintained at all times.

Trading Operations and Traceability

·

Support the QRP in overseeing trading operations and documenting every transaction accurately, ensuring traceability of pharmaceutical purchases and sales.

·

To collect and retain documentation demonstrating the quality of procured medicinal products.

·

To collect and review all necessary documents that demonstrate the quality of the medicinal product traded.

·

To facilitate the exchange of all information relevant to product quality between the customers and the suppliers.

·

Support the QRP in overseeing the accuracy and correctness of SAP configurations pertaining to the generation of documents that are relevant to Good Distribution Practices (GDP).

·

Support the QRP in dispositions of batches that require Swiss QRP assessment when applicable.

·

The QRPD may act on behalf of the QRP during documented absences. Such delegation shall be documented internally and supported by the training matrix.

Trading Partners

·

Support the QRP in managing a system for the verification of the conformance of suppliers and customers to register, manufacture, test, dispatch, store, receive and distribute pharmaceutical products into the market.

·

To contribute to the review of quality and technical agreements related to the supply of medicinal products and, when formally delegated, sign on behalf of the QRP during documented absences.

Recalls and Counterfeit

·

To support the maintenance of an effective recall procedure.

·

To identify falsified medicinal products and to avoid or, using the appropriate measures, to prevent them from reaching the legal sales channels.

Storage & Transport

·

To support the maintenance of a system ensuring that storage facilities and premises used for the intermediate storage of the goods traded or during their transport must be qualified for storing pharmaceuticals.

·

To liaise with the relevant stakeholders to support that transport conditions for all pharmaceutical deliveries are suitable across the entire supply chain, with requisite documentation available and continuous monitoring of conditions.

·

To collaborate with designated Teams for Transport verification processes, Risk assessments.

*#

Additional Responsibilities

#*NA*#

Reporting Team

Reporting Designation

#*

Quality Manager & Responsible Person

*#

Reporting Department

#*Quality Assurance*#

Educational qualifications preferred

Category

• #*Degree in Pharmacy or higher studies (university or equivalent / higher technical institute) in the area of natural sciences (or if applicable medicine or engineering) are accepted.
• •

• Experience in the pharmaceutical area in responsible functions e.g. as GMP/GDP environment for at least 1 year.
• *#

Field specialization

#*Field specialization*#

Degree

#*Degree*#

Academic score

#*Academic score*#

Institution tier

#*Institution tier*#

Required Certification/s

#*Required Certification/s*#

Required Training/s

#*Required Training/s*#

Required work experience

Industry

#*·

• Experience in responsible pharmaceutical quality functions, such as Responsible Person, QMS Specialist, Quality Assurance Associate or equivalent.
• *#

Role

#*Role*#

Years of experience

#*Years of experience*#

Key Performance Indicators

#*Key Performance Indicators*#

Required Competencies

#*Required Competencies*#

Required Knowledge

#*Required Knowledge*#

Required Skills

• #*
• The Responsible Person Deputy is required to have a proficient command of the English language, and as well the Swiss national language spoken in the canton where the company is registered, which for GSSA is French.
• *#

Required abilities

Physical

#*Physical*#

Other

#*Other*#

Work Environment Details

#*Work Environment Details*#

Specific requirements

Travel

#*Travel*#

Vehicle

#*Vehicle*#

Work Permit

#*Work Permit*#

Other details

Pay Rate

#*Pay Rate*#

Contract Types

#*Contract Types*#

Time Constraints

#*Time Constraints*#

Compliance Related

#*Compliance Related*#

Union Affiliation

#*Union Affiliation*#