Responsible Pharmacist

MNA Recruitment (Pty) Ltd; Gauteng; On-site; ZAR 600 000 - 900 000; Full time

Job summary

A leading pharmaceutical company is seeking a Responsible Pharmacist to oversee regulatory affairs, quality control, and compliance. The ideal candidate will have a Bachelor of Pharmacy and extensive experience in the pharmaceutical industry, ensuring patient safety and adherence to regulations. This role involves managing pharmacy operations, regulatory submissions, and maintaining high standards of quality in products.

Qualifications

• Registered Pharmacist with South African Pharmacy Council (SAPC).
• 10-15 years of relevant experience.

Responsibilities

• Compile and submit registration dossiers in accordance with MCC requirements.
• Ensure compliance with legislative specifications and standards.
• Oversee activities of the pharmacy and train staff.

Skills

Regulatory Affairs

Pharmacovigilance

Quality Control

Compliance

Customer Service

Education

Bachelor of Pharmacy (BPharm)

Job description

A leading pharmaceutical company has a vacancy for a Responsible Pharmacist.

Key Responsibilities

Regulatory Affairs :

• To compile and submit registration dossiers in accordance with the specific requirements of MCC
• Dossier Maintenance : Submission of post registration variations in line with regulatory requirements.
• Submission of updated product Package insert or labelling updates in line with regulatory requirements.
• To align regulatory product registration submission strategy to commercial product strategy
• Review of promotional materials to ensure adherence to country specific requirements Pharmacovigilance :
• Act as a Pharmacovigilance contact for Regulatory Authority (MCC) and ensure timely response to regulatory authority queries and request information
• Coordinate with Global PV cell and ensure timely submission of ADRs to the respective regulatory authorities
• Report processed ADRs to the local Regulatory Authority (MCC) as applicable, in accordance with local regulations and maintains a submission log.
• To handle (liaise with customers, patients and doctors where required) all of South African organization PVG complaints and PQCs
• PV Training of all employee having customer interface
• Commercial – Responsible for tender business which includes ensuring participation in all relevant tenders floated by tender authorities in South Africa. Work towards improving success of winning percentage over the bid value by efficient coordinating with internal stake holders for right pricing, supply and regulatory strategies. Should be vigilant about changing requirements which will influence future success including BEE compliance and local manufacturing.
• Maintain, drive, supervise and implement robust technical standards, systems and processes.
• Provide direction and support to ensure compliance with relevant legislative specifications and standards
• Identify the key trends in local MOH policies and advocate the Business team for compliance and suggest ideas for business growth.

QA / QC Function :

• Ensuring quality check for each product batch imported in SA through assigned labs and release of stocks
• Oversees local quality assurance and quality control concerning all the company’s products
• Ensure maintenance and compliance of existing products in accordance with the Drug regulatory Authorities requirements
• Auditing of third party manufacturers, Distributors and Quality control labs
• Participating in International Drug regulatory authorities audits conducted at manufacturing sites

General : Compliance :

• The RP ensures the pharmacy adheres to all applicable laws, regulations, guidelines, and codes, must ensure the pharmacy's license conditions are met. This includes staying current with legislative changes and implementing necessary procedures.

Supervision and Management :

• The RP oversees the activities and actions of the pharmacy, ensuring they comply with regulations, are responsible for the training and supervision of pharmacy staff, including interns and technicians. Also ensure the ongoing competency of pharmacy professionals.

Safe Storage and Record Keeping :

• The RP is responsible for the safe and effective storage and record-keeping of medicines. This include : maintaining accurate records of purchases, sales, possession, storage, and return of medicines and controlled substances.

Quality Control :

• In manufacturing pharmacies, the RP ensures management operates in accordance with Good Manufacturing Practices (GMP). Also play a vital role in ensuring the quality of manufactured drugs through quality control checks and adherence to procedures.

Patient Safety :

• The RP is responsible for ensuring the safety of patients by verifying dosages, identifying potential interactions, and educating patients about medications. Must counsel patients about their medications, including proper use, potential side effects, and interactions.

Other Duties :

• The RP may be involved in developing and optimizing production methods, testing and validating products, and troubleshooting issues in manufacturing settings. May also prepare reports as required by the company.
• The RP may be involved in regulatory affairs, ensuring timely approvals of post-registration amendments and compliance with registration dossiers.

Customer Service :

• The RP may be involved in managing product complaints and initiating recalls, if necessary, to address quality or safety concerns.

Requirements :

• Bachelor of Pharmacy (BPharm) and / or equivalent qualification
• 10-15 years of relevant experience
• Registered Pharmacist with South African Pharmacy Council (SAPC)

Candidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com

Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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