11 Jan '21
QA and HSE Manager

Medical, Gauteng Gauteng

market - related

A Global Pharmaceutical Company has a vacancy for a QA and HSE Manager.

Job Purpose:

  • Manage the daily Quality Assurance and Health, Safety and Environment activities of the Company's Animal Health facility including the Warehouse to ensure the smooth functioning of all associated departments.
  • Organising and co-ordinating the activities of the department and motivating staff to ensure maximum output.
  • Ensuring adequate staff development.
  • Nurturing and maintaining vitally important relationships both internal and external suppliers and customers.
  • Coordination of timeous delivery of quality supplies from contract manufacturers and packers including SHEA Logistics and suppliers of packaging material.
  • Supplier Performance Management – to ensure Quality standards in product manufacture by thirds party service providers meets the standards required.
  • Contract Management – to prepare and implement and maintain appropriate forms of contract and commitment with suppliers
  • To ensure compliance with all legal requirements as Deputy Responsible Pharmacist, as stipulated by the Pharmacy Act (Act 53 of 1974), in the absence of the Responsible Pharmacist.
  • To ensure compliance with all legal requirements as stipulated by the South African Health Products Regulatory Authorities (Act 101 of 1965).
  • To ensure compliance with all legal requirements as stipulated by the Fertilizer, Farm Feeds, Agricultural Remedies and Stock Remedies Act (Act 36 of 1947) and the Animal Diseases Amendment Act (Act 18 of 1991).
  • To ensure compliance with all legal requirements relating to the practices of a Pharmaceutical facility, with respect to the facility.

Key Responsibilities:

COMPLAINTS

  • To ensure that all product complaints received are investigated and identified as to the nature of the problem and is directed to the Quality Assurance department.
  • To ensure that product complaints involving "adverse drug reactions" are directed to the Pharmacovigilance department within one business day or three calendar days, whichever is shorter.
  • To ensure that product complaints are noted and kept on file and followed up in a procedurally correct manner.
  • To follow-up product complaint investigations with contract manufacturers and ensure closure and reporting of the investigations to the organization.


RECALL

  • To be able to handle a medicines 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.


RETURNED / REJECTED GOODS

  • To ensure that goods returned 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.


GMP / GWP

  • To ensure that the facility complies with all GWP and GMP requirements as specified by the SAHPRA.


DISTRIBUTION PRACTICES

  • To ensure that the current distribution practices that are in place provide for the adequate distribution of products to customers in terms of Quality and Safety of products.
  • Oversee secondary re-packing/re-labeling that is done.
  • Oversee and ensure control over the retention samples and retention sample store.


INBOUND SERVICES

  • Manage and oversee the activities of contract manufacturers, packers and suppliers to ensure timeous supply of quality product to the company.
  • Ensure that the facility uses the services of approved suppliers for manufacturing of the company’s products and supply of packaging material.
  • Nurturing and maintaining vitally important relationships with suppliers.


PHARMACOVIGILANCE

  • In the event of receiving any communication relating to an Adverse Event / Product Quality Complaint, the employee shall, within one (1) business day or three (3) calendar days, whichever is shorter from the date of receipt of such communication, notify the pharmacovigilance department by email
  • To cooperate fully with, and provide all reasonable and necessary information and assistance to the pharmacovigilance department in connection with any investigation relating to the report.


QUALITY ASSURANCE AND CONTROL

  • Overseeing the safe handling of all goods with respect to local manufacturing, warehousing and internal transport
  • Ensuring that the outsourced distribution arm is in compliance with local applicable legislation.
  • Overseeing of the handling of goods with respect to GMP/GWP procedures viz. Returned goods etc.
  • Regular auditing and ensuring GMP compliance of local manufacturing facilities and company as whole
  • Writing up all relevant SOP’s and ensuring compliance with these SOP’s, with respect to Quality Assurance and Health, Safety and Environment in the Warehouse
  • Training with respect to GMP and GWP
  • All other duties as required to ensure legal compliance of company with SAHPRA and SA Pharmacy Council
  • Overseeing the local manufacturing and secondary packing of all products and Inspection of the third party packers.
  • Responsible for the final release of product onto the market as directed by the Responsible Pharmacist.
  • Provision of laboratory service to clients, in testing of feed additives concentration in final feed mixes.


HEALTH AND SAFETY

  • Ensuring safety standard in the facility by adhering to OHS Act requirements and Global Standards.
  • Conduct regular health and safety audits of the facility.
  • Liaise with GSE and local EHS team to ensure EHS compliance

 

Knowledge and Experience Required

  • Registered pharmacist
  • Computer literate
  • Inventory management systems – SAP experience would be advantageous
  • Health and safety experience
  • QA distribution and Third party manufacturer experience
  • People Management


ACCOUNTABILITY MEASURES

  • Rand Measures
  • Drive Cost Savings – Identify, Track and Deliver cost reduction opportunities
  • Work as close as possible within the agreed budgets.
  • People Measures
  • Ensure healthy department relations to maximize output from department


PERFORMANCE DIMENSIONS

  • Good planning and organising skills
  • Effective Communication
  • Technical/professional knowledge
  • Service orientation
  • Adaptable
  • Initiative
  • Very Analytical
  • Ethics and integrity
  • Tolerance to stress
  • Energy
  • Highly Motivated
  • High job standards
  • Ability to work under pressure
  • Conflict Management

 

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.

 

 

 

 

Ad Visible Until: 31 January 2021
Ref: DBN002837/SS

Vacancy Type: Permanent