QA Manager and Responsible Pharmacist

3 days ago

East London, South Africa Aspen Pharma Group Full time

**Company Description**

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

**Purpose of Position**:
To Implement and maintain a Quality Management System compliant with GDP/GWP requirements. To ensure compliance of the warehouse to pharmaceutical requirement as stipulated by SAHPRA.

**Key Responsibilities**

**OPERATIONAL ACTIVITIES**:

- Follow and resolve all distribution quality queries in the shortest possible timeframe within policy framework.
- Display a professional attitude when responding to customer’s needs.
- Propose and continuously develop methods to improve customer services.
- Respond to distribution quality related complaints and liaise with customer and regulatory affairs.
- Interact with SAHPRA & SAPC.
- Liaise with Aspen QA Managers relating to quality issues

**QUALITY MANAGEMENT SYSTEMS**
- Ensure that site is informed and aware of the Quality policies.
- Direct and manage the Quality Management System.
- Monitor key performance areas relating to quality.
- Establish quality plans for the warehouse.
- Generate, maintain, monitor and review SOPs to ensure effectiveness.
- Ensure training of quality procedures for site
- Ensure training of desired level of GDP/GWP
- Develop and train own staff
- Ensure availability of training records for inspection
- Direct and manage implementation of applicable quality standards
- Monitor VMP, review and authorize VMP
- Monitor and review calibration and validation status of equipment
- Ensure effective Change Control and Deviations control and management system is in place.

**MONITORING AND MEASUREMENT**
- Review processes to ensure compliance for audits
- Ensure compliance to procedures, GDP/ GWP and regulatory requirements.
- Monitor temperature and humidity, analyses data and compile reports
- Ensure Non-conformances are recorded, investigated and corrective action implemented

**AUDITING**
- Plan internal audits
- Conduct internal audits - ongoing
- Write reports and follow up on corrective actions
- Feedback to senior management
- Facilitate Vendor audits as when required
- Compliance to procedures, GMP/GDP/GWP and regulatory requirements

**REGULATORY**
- Compile and maintain site master file
- Review and inspect for regulatory compliance
- Familiarize with PIC, FDA and MHRA / MCC standards
- Ensure compliance to regulations for relevant markets
- Report to Distribution Manager regarding operational requirements
- Maintain relevant delegation letters
- Maintain licenses for premises and personnel to MCC, SAPC and DOH
- Ensure SLAs are in place with relevant Service Providers
- Review and maintain Technical Agreements/SLA’s to ensure quality matters relating to warehousing/distribution of pharmaceutical goods is clearly addressed

**STOCK CONTROL**
- Stock losses should be minimized by implementation of appropriate security measures
- Monitor stock discrepancies by reviewing inventory adjustments performed and cycle count results
- Report on stock losses using internal reporting structures, and when required, the relevant regulatory authorities.
- Compile Annual International Narcotics Control Board Report for submission to the Department of Health (DOH)
- Oversee compilation of monthly reports on Export permits / Schedule 5 & 6 medications

**RECALLS**
- Assist Manufacturer/ Applicant/Holder of Certificate of Registration with recall process

**TRAINING**
- Oversee training for site both internal and external
- Oversee Induction and SOP training
- Oversee SOP training
- Oversee training profiles for employees

**GENERAL**
- Ensure compliance with SHE requirement
- Ensure that Health and Safety procedures are adhered to, and correct PPE are used
- Repair and maintenance of equipment and facilities

**MANAGEMENT**
- Manage departmental financial, SHE, HR and GMP responsibilities and activities
- Plan, lead, allocate and manage departmental activities, resources, and tasks in accordance with agreed budgets, service/delivery targets and daily/weekly/monthly plans
- Establish and maintain appropriate systems for operational management and measurement
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