Responsible Pharmacist - Midrand (Contract) - Midrand Verfied

Salary Negotiable Midrand, Gauteng Midrand, Gauteng more than 14 days ago 26-11-2014 3:16:09 PM
24-12-2014 3:16:09 PM
Strict screening in terms of requirements will be adhered to. Only applications with the below experience and skills will be considered.

PURPOSE OF THE JOB:
To ensure that the organisation meets its statutory requirements in terms of the SA Pharmacy Act 53 of 1974 and the Medicines and Related substances Act 101 of 1965 as amended from time to time in order to ensure compliance to maintain a pharmaceutical distribution license.
Authority, duties and responsibilities of the Responsible Pharmacist as reflected in terms of Regulation GN 1158, “Regulations Relating to the Practise of Pharmacy” Section 25 of the Regulations of the Pharmacy Act (Act 53 of 1974).

EDUCATION AND EXPERIENCE:

Minimum B Pharm
MINIMUM 3 YEARS IN SAME POSITION
Clear ITC and criminal record
Driver's licence
Experience in Manufacturing and, or distribution (GMP; GWP; GDP are all principles applied in manufacturing/distribution
Good MANUFACTURING PRACTISE STANDARDS / GOOD WAREHOUSE PRACTISE STANDARDS / GOOD DISTRIBUTION PRACTISE Standards
Registered with South African Pharmacy Council
Experience in Compilation of Standard Operating Procedures (SOP's)
Knowledge of SA Pharmacy Act, Medicines and Related substances Act / MCC guidelines
Risk management
Pharmacovigilance Knowledge
Knowledge of Occupational Health and Safety Act and its regulations
Basic MS Office skills
MCC guidelines Recall, complaints handling, returns, corrective and preventative actions, change control, audits and stock management.
Quality Assurance
Quality Risk management
Quality Management System
Cold Chain management
Expected to work some level of overtime
Project Management
Report Writing
SOP Compilation
Assertive
Work Under Pressure
Analytical
Pro-active
Position Description:
OPERATIONAL EFFECTIVENESS:
Ensure operational effectiveness by receiving products, storage and dispatch as per SOP requirements. Ensure that products adhere to cold chain maintenance throughout the distribution process.
COMPLAINTS:
To ensure that all product complaints are investigated and identified as to the nature of the problem and are given the necessary attention.
To ensure that product complaints involving “adverse drug reactions” are reacted upon and followed up without delay.
To ensure that product complaints are noted and kept on file and followed up in a procedurally correct manner.
Receive all complaints and complete the necessary documentation eg. Log sheet and form
Ensure that procedure for handling complaints is available and followed.

RECALL:
To be able to handle a medicines withdrawal or recall according to correct procedure.
To ensure that all batches of medicine distributed are batch traceable in the event of a recall and that all invoices carry batch numbers.
To take the final decision on a recall, after consultation with any relevant personnel.
To ensure that the Medicines Regulatory Authority (MRA) and Principals are informed immediately of any possible withdrawal of unwanted medicine from the market.
Ensure that recall procedure is available, it is followed, forms and log sheets are completed.

RETURNED / REJECTED GOODS:
To ensure that goods returned to the applicant via the distributor (or by the distributor on behalf of the applicant) are handled in a procedurally correct manner, reason for returns determined and any further actions followed through and recorded.
To ensure that goods due to be rejected or reworked are handled in a procedurally correct manner.
To be responsible for the final decision, after consultation with relevant personnel, to re-pack certain returned goods or to destroy rejected goods.
Ensure that procedure is available and followed.
Ensure investigations are performed where relevant.

GMP / GHP / GWP / GDP:
To ensure that all employees are conversant with the system laid down for using and following the STANDARD OPERATING PROCEDURES.
To ensure that inspection audits are performed on all third party contractors whereby it is established that written systems are adhered to and all operations are carried out in accordance with approved, written procedures.
To ensure that disposal or destruction of medicines is correctly performed under proper control so as not to be a health hazard.
To ensure that an adequate pest control programme is in place at the distribution facility, using acceptable food grade bait, and to ensure that precautions are taken to ensure that product contamination does not occur.
To ensure that self-inspection audits are performed and any deviations followed up.
To ensure that final packaged product on arrival at the distribution facility is placed in quarantine, sampled for re-testing after importation, and retained in quarantine until formally released.
To check all relevant documentation in order to formally release final packed product or locally packed imported bulk for distribution.
To ensure that all materials received are recorded on batch records and any discrepancies recorded under non-conformances
To ensure that all change controls, deviations, corrective and preventative actions are recorded.
Storage facilities are qualified where applicable and the transport system is also validated where required.
Maintenance of equipment is performed and no equipment is used when it is not safe to do so.
Batch records are stored and training given to employees

QUALITY MANAGEMENT SYSTEM:
Ensure regulatory and statutory requirements are met by regular inspection of facilities, ensure that licences are up to date.
Ensure cold chain compliance for Vaccine distribution by validating the fridges and the boxes.
Communicate with regulatory bodies for queries and inspections on an ongoing basis.
Ensure that Validation and Qualifications are in place for compliance.
Implementing the QMS at the facility in order to comply with standards.
Ensure that personnel are trained and training programmes available.
Liaising with the MCC, Pharmacy Council and Department of Health.
Liaising with service providers & principals

ADMINISTRATION:

Ensure performance management of staff.
Manage projects on an on-going basis eg. new legislation impacts distribution of new products - relabeling of products.
Filing and storage of documentation.
Ensure that he in fact continuously supervises the pharmacy in which he or she has been appointed.
Ensures that persons employed in Vaccines division and who provide services forming part of the scope of practice of Vaccines are appropriately registered with council.
Notify Council (SAPC) immediately upon receiving knowledge that his services as responsible pharmacist have been or will be terminated.
Takes corrective measures in respect of deficiencies with regard to inspection reports of Council (SAPC) and/or in terms of the Medicines Control Act; and
In addition to the general responsibilities also:
Ensures that unauthorised persons do not obtain access to medicines or scheduled substances of the Vaccines premises outside of normal trading hours.
Establishes policies and procedures for the employees of Vaccines with regard to the processes performed and services provided in the Vaccines company.
Ensures the safe and effective storage and maintenance keeping of medicine or scheduled substances in Vaccines premises under his / her direct personal supervision; and
Ensures correct and effective record keeping of the purchase, sale, possession, storage, safekeeping and return of medicines or scheduled substances.

LEGAL:
Ensure compliance with statutory regulatory and quality requirements
To identify and resolve any regulatory and quality non-compliance.
To ensure registration of RP and licensing of the company with Authorities.
To ensure that the name of the RP is prominently displayed over entrance.
To ensure that a Designated Deputy (DD) is in control of the facility should the RP be absent.
To ensure that directors (when applicable) are au fait with the latest ethical rules of SAPC, the SA Guide to GMP and sign agreements to abide thereby.
To ensure that contracts exist between applicant and 3rd party contract acceptors stipulating where all responsibilities lie.
To ensure that medical representatives (when applicable) are correctly trained, as to the legal requirements and products for detailing.
Communication with regulatory bodies in terms of audit findings and reports.
Ensure that qualified personnel are employed.

Package: R35k-42k per month TCTC, depending on experience.

Should you not have received a response to your application within two weeks of submitting your CV, please consider your application unsuccessful. Your CV will be kept on file for any further suitable positions.