Responsible Pharmacist & Regulatory Affairs / Quality Assurance Pharmacist – Johannesburg

JOB PURPOSE

Responsible Pharmacist:

The Responsible Pharmacist is a natural person who is a pharmacist and who shall be responsible to the council for complying with all the provisions of the Pharmacy Act No. 53 of 1974 and other legislation applicable to services which specially pertain to the scope of practice of a pharmacist, and the legislation applicable to the pharmacy which is under his or her personal supervision

 

Regulatory Affairs:

To ensure company compliance with regulatory requirements relating to the submission and maintenance of medicines in South Africa and other designated territories

 

Quality Assurance:

To ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa, including the product complaint reporting process, product release, internal and external audits and GMP training

 

The right candidate must be experienced, goal driven and must be able to work independently.

 

FUNCTIONS & RESPONSIBILITIES

(but not limited to)

 

Responsible Pharmacist:

Contemplated in regulation 25 (3) of the Pharmacy Act and the relevant sections of the

Medicines Act shall:

 

Ensure that he or she in fact continuously supervises the company

Have appropriate qualifications and experience in the services being rendered by the company

Ensure that persons being employed by the company and who provide services forming part of the scope of pharmacy practice of a pharmacist are appropriately registered with the Pharmacy Council

Notify the Pharmacy Council immediately upon receiving knowledge that his/her services as responsible pharmacist has been or will be terminated

Take corrective measures in respect of deficiencies regarding inspection reports of the

Pharmacy Council or in terms of the Medicines Act, and in addition to the general responsibilities as well

Ensure that unauthorized persons do not obtain access to medicines or scheduled substances or the pharmacy premises outside of normal trading hours

Establish policies and procedures for the employees of the pharmacy regarding the acts performed and services provided in the pharmacy

Ensure the safe and effective storage and keeping of medicine or scheduled substance in the pharmacy under his or her direct personal supervision

Have the overall responsibility for release of the finished products to the market

Ensure correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances

Initiate and co-ordinate all recall activities which should involve the Quality Assurance Pharmacist

Compile a letter of delegation of authority in his/her absence.

Control the manufacturing or distribution of medicines, scheduled substances, or medical devices in terms of the provisions of the Medicines Act, 1965

Ensure that there is compliance with Good Pharmacy Practice as published by the Pharmacy Council

Be part of the decision-making process affecting the pharmacy business

 

Ensure that the pharmacy owner complies with all the conditions of:

– ownership of such pharmacy business

– registration of the pharmacy

 

Ensure that no person is appointed to perform any act falling outside the scope of practice of the category in which such person is registered or which he/she is not authorized to perform in terms of the Pharmacy Act, 1974 (Act 53 of 1974)

 

Report in writing any non-compliance with the Pharmacy Act to the management of such pharmacy business and furnish Pharmacy Council with a copy thereof

 

Not introduce or carry out any instruction or order of management with regard to the pharmacy business of the pharmacy owner which could amount to a contravention of legislation applicable to such pharmacy business and be responsible to the Medicines Control Council for compliance with the provisions of the Medicines and Related Substances Act, 1965 (Act 10 of 1965) relating to the sale control of the manufacturing and distribution of medicines, scheduled substance or medical devices

 

Regulatory Affairs Pharmacist:

Delivery of annual product submission plan:

  • Compiling/overseeing submission of dossiers according to annual product submission plan to SAHPRA and regional Medicines Regulatory Authorities within SADC
  • Due diligence on prospective dossiers from India as well as other third parties

 

Delivery of Future Registrations:

  • Continuous liaison with SAHPRA to ensure new product registrations are received on time to satisfy the requirement of the business
  • Compile/oversee that recommendations are responded to timeously

 

Life Cycle Management:

  • To ensure that necessary updates are made to the Registration Dossier according to latest requirements of the MRA, including conversation of dossiers to the ZA-CTD
  • To ensure timely approvals of post registration amendments to avoid out of stock
  • To ensure that the MRA is informed of changes to the registration dossier

 

Printed Packaging Material Review:

  • Review for compliance with the registered dossier and final approval before print (APLSA and third parties)

 

Marketing Material:

  • Provide regulatory support during concept design of all new marketing material
  • Ensure compliance of all marketing material with the Marketing Code Authority and legislation

 

Quality Assurance / Compliance:

Overseeing compliance to batch documentation review, annual product reviews, trend analysis and overall quality risk management

Ensuring adherence to SAHPRA and GMP guidelines by all relevant personnel

SOP review and approval, creation of new SOPs as and when required

Vendor inspection audits when required

Overseeing the handling of technical product complaints and queries in accordance with the guidelines and requirements

Providing feedback to the business regarding any quality issues in the Quality Management Review

 

Training & Support:

Providing training and support to Regulatory Affairs Pharmacist and Assistants

Training and implementation on new SAHPRA guidelines

Training to sales and office personnel on Pharmacovigilance and other relevant subjects when Required

 

Third Party:

Liaising with India on all regulatory and quality assurance activities

Co-ordinating GMP/GCP inspections of parent company’s manufacturing facilities with inspectors from the various Regulatory Authorities

Controlling correspondence with other pharmaceutical companies and pharmaceutical consultants with regards to regulatory activities

Vendor inspection audits of distributors and laboratories

Finalizing agreements with third party contract laboratories

Customer relationship management with all third parties mentioned above

 

Pharmacovigilance:

Collection of adverse drug reactions and reporting it to the global Pharmacovigilance

department

Providing Pharmacovigilance training and documenting these training activities

Provide global Pharmacovigilance with sales data and regulatory information on request

Keep abreast with applicable South African laws, rules and regulations and keep global Pharmacovigilance informed of significant developments relating to Pharmacovigilance

Ensuring “Dear Healthcare Professional” letters are sent out in the event of urgent safety updates

Overseeing that package inserts are updated to reflect the latest updated safety information

 

Local Manufacturing Technical Responsibilities:

Ensure that CMO remains GMP compliant and complies with all local legislation and requirements as per the product dossiers

Ensure that all batch documentation is reviewed, and releases are done appropriately to ensure that safe and quality products are released to the public

To provide technical support to the CMO regarding any queries or concerns related to any of the company’s products

 

REQUIREMENTS

  • Matric
  • Bachelor of Pharmacy Degree
  • Previous working experience in Production and Quality Assurance – advantageous
  • 5 years’ experience in a Regulatory Affairs department
  • Must be Computer Literate

 

Must have a thorough understanding of the laws and regulations governing registration of

medicines in the applicable territories

 

Skills & Attributes:

  • Organizational & Managerial Skills
  • Problem Solving
  • Analytical Skills
  • Service Orientation
  • Decision Making Skills
  • Interpersonal Skills
  • Report Writing Skills
  • Attention to Detail
  • Initiative
  • Confidentiality
  • Customer Focused
  • Logical Thinking
  • Information
  • Seeking
  • Sense of Urgency

 

 

Should you meet the above requirements, we urge you to please apply by forwarding your CV along with any supporting documents to info@glass-house.co.za

 

Contact will only be made with shortlisted candidates. Should you not hear from us within two weeks, please consider your application unsuccessful

 

More Information

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