QA Manager and Responsible Pharmacist (EE/AA)(Permanent) - Cape Town - iS065YX95L

Our client requires the service of a suitably qualified / experienced Quality Assurance Manager and Responsible Pharmacist.

POSITION: Permanent

COMMENCEMENT: As soon as possible

Reports into: Technical Manager

Direct reports: 8

Purpose of Position:

The Quality Assurance Manager has the primary responsibility to Implement and maintain a Quality Management System compliant with GMP/GDP/GWP requirements. To ensure compliance of the production facility to pharmaceutical requirement as stipulated by SAHPRA.

Ensure compliance with regulatory requirements on product, process and release procedures.

Key Relationships:

Internal:

Head of Departments

All employees

External:

Auditors

Regulatory authorities (SAPHRA / DOH / SAPC)

Suppliers

MINIMUM REQUIREMENTS:

• Bachelor of Pharmacy Degree
• Registered with the SAPC (South African Pharmacy Council) as Responsible Pharmacist
• Experience in pharmaceutical manufacturing sector
• Experience in working with various Regulatory Authorities and Auditing institutions
• To be conversant with the Medicines Control Act and Pharmacy Act
• Experience in leading a team

JOB OUTPUTS (KPI’s):

Compliance to Regulations and Acts

• Ensure compliance to all legal & regulatory requirements, including but not limited to:
  • Medicines and Related Substances Control Act (Act 101 of 1965)
  • SAPHRA & SPC
  • GMP, GLP, GWP

Quality Management System

• Maintain an effective Quality Management System.
• Ensure that corrective measures are implemented in respect of deficiencies with regard to inspection reports of Council, or in terms of the Medicines and Related Substances Control Act (Act 101 of 1965)
• Ensure timeously revisions of related documentation, included but not limited to:
  • Site Master File
  • Quality Manual
  • Cleaning Validation Master Plan
  • Quality Risk Management

Quality Management System Review Meeting

• Convene the QMS Review Meetings every 6 months.
• Evaluate compliance with existing systems and procedures i.e. CAPA (Non-conformances, Deviations, Returns, Rejects, Reworks etc.); and compile CAPA information for the QMS Review
• Compile the associated QMS Review Meeting reports

Quality Risk Management

• Ensure the relevant Risk Assessments are initiated, as required.
• Compile / assist with compiling the associated Risk Assessment Reports
• Ensure that QRM is performed to meeting regulatory requirements
• All risk is reduced/mitigated and controlled
• Controlled risk is accepted

Company Audits

• Ensure audits are initiated and/or facilitated as and when required, included but not limited to:
  • External/Internal audits
  • GMP audits
  • Supplier audits
  • Desktop & technical audits
• Ensure compilation & submission of various audit reports
• Follow-up to ensure timeous close-out of findings.

Qualifications

• Review and approve protocols and reports pertaining to qualifications relating to:
  • Facility & Utilities
  • HVAC
  • RO Water system
• Ensure compliance to Planned Preventive Maintenance and calibrations schedules

Change Control

• Ensure effective management of the Change Control system within the Company.
• Ensure that all changes are assessed for impact and measures are taken to reduce or eliminate the impact to product quality
• Review all change controls in concordance with MCC Post Amendment Guideline
• Changes are closed within a specific time period and any deviation documented and justified
• Perform the necessary communication if required, with the relevant authorities and the public

Customer Complaints

• Ensure all customer complaints are processed and investigated in accordance with the relevant procedures.
• Release & Recalls
• Place production on hold if product is not meeting / or manufactured as per legislative requirements
• Review batch and testing documentation and approves release for sale or distribution
• Recall products if required
• Sign off batch releases

Annual Product Reviews

• Review annual product review reports
• Ensure compliance with annual schedule

Training & SOP’s

• Generate, maintain and monitor SOP`s to ensure effectiveness
• Consult with Management and update SOP`s & WI`s when required
• Ensure training for quality measures on site
• Ensure training of desired level of GMP, GDP, GLP
• Oversee the Training Program for the Company
• Ensure that Training Plans are in place for all staff.
• Assist Managers to identify training needs within their departments and put measures in place to ensure continuous compliance to GMP standards.
• Ensure that all newly promoted or appointed staff have undergone the following training:
  • Induction
  • GMP
  • Ongoing Refresher
  • OHSE

Employee Management

• Builds and develops the team, and manages the team directly and is responsible for their performance, for recruitment and selection of new members
• Organises the team and their duties in a way that achieves synergy across the departments

Master Documentation

• Ensure strict controls are in place for the issuing and printing of Master Production Batch Records/documentation, including but not limited to:
  • Manufacturing, packing & picking slips
  • Line opening and closing documentation
  • Printing of Master Documents
• Liaise with the Regulatory Affairs Manager with regards to updating of all master documents in relation to the change/deviation/non-conformance in manufacturing.

New Product Development

• Provide technical support to the new product development program in terms of:
• Formulation trials
• Process optimization
• Review of batch documentation, as required

Pest Control

• Ensure that an effective pest control program is in place throughout the facility.
• Investigate and address any reported anomalies