Contract QA Assistant- Pharmaceutical
Please note that this is a contract position that will end 31 December 2021
To assist in completing all routine Quality Management System tasks and administrative duties as required by the company in order to ensure the required quality standards and specifications are maintained.
To ensure that all quality matters and related topics of the operational business comply with GxP, legal, regulatory and company requirements.
Ensure that IPQS pharmacist are supported in effectively using QMS systems to ensure QA compliance and no interruptions in core business activities.
Maintain Quality Systems in such a way to prevent significant quality issues, stock out situations, or scenarios which would negatively impact the financial performance of the company or cause harm to the reputation of the company.
Support the local business in the movement towards a state of perpetual compliance.
Support continuous improvement efforts to ensure that the QA team adheres to local and international best practises
Take responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of Conduct.
KEY PERFORMANCE INDICATORS
KEY RESULT AREA 1: Assist with the batch release process
To ensure that products are released for sale in accordance to requirements and within agreed lead times.
1. Record all the batches in the IPQS batch tracking log, and inform the relevant IPQS QA Pharmacist of the batch arrival.
2. Assess if the batch requires IPQS to send QC samples for testing to the relevant laboratory (locally or overseas), and arrange for the samples to be sent accordingly.
3. Obtain all the relevant batch documents including CoA’s and shipping temperature data and prepare them for review by the relevant IPQS QA Pharmacist. Follow-up with sites / supply chain until relevant CoA’s / CoC’s are obtained.
4. Obtain the quotes from the relevant laboratories for the testing of the batches, and raise PO’s in a timely manner. If quotes are not received, follow-up with the laboratory in question in order to ensure that laboratory results are not delayed due to quotes that have not been received.
5. Ensure all sample handling is conducted according to product storage and transport requirements.
6. Ensure that any documents that must still be retained on the site are submitted for storage through the Metrofile system.
7. Monitor the container where used temperature loggers are kept on a regular basis to ensure loggers are destroyed on a regular basis in order to prevent accumulation in the IPQS department.
8. Send temperature loggers to overseas sites (if required).
9. Order new loggers for IPQS department for shipment of samples.
10. Maintain the CoA / CoC and PIT results storage and ensure relevant documents are filed with appropriate naming convention per batch in order to ensure easy retrieval.
11. Maintain internal tracking system to ensure batch release is completed within the required timeframe.
KEY RESULT AREA 2: Assist with the maintenance of the relevant SOP’s in the ESOPS D2 system
To ensure that all SOP for which IPQS is responsible for are updated in a timely manner and that training of these SOP’s are rolled-out on UP4GROWTH.
1. Enter all relevant SOP’s into the ESOPS D2 system as the drafts become available from the relevant authors.
2. Ensure the relevant SOP’s are routed for review and approval.
3. Once a SOP is published, ensure the relevant SOP is loaded onto Up4Growth, and training is as-signed to the relevant associates as advised by the author of the SOP.
KEY RESULT AREA 3: Assist with the training management system in the IPQS department
To ensure that relevant training for IPQS is rolled-out on Up4Growth as required.
Assist with the training management system in the IPQS department, by:
1. Act as a department training coordinator for the IPQS department.
2. Ensure all relevant SOP training is rolled out to the applicable stakeholders as new procedures are updated in order to ensure that new revisions of these documents are correctly trained.
3. Assist with the loading and rolling out of training materials on Up4Growth as required.
4. Assist with obtaining training reports from Up4Growth as required.
5. Capture manual training sessions and maintain records.
KEY RESULT AREA 4: Assist the IPQS department with system role owner duties and general system maintenance
To ensure that role owner and general maintenance duties within the IPQS department is properly overseen and managed.
Assist the IPQS department with general administrative duties by:
1. Requesting information / documentation required to conduct routine tasks within the QA depart-ment. As example: DRA, Supply Chain and Finance information.
2. Collating collected information into appropriate trackers / IPQS documentation and share as re-quired within the department.
3. Collect information / documentation from Quality Systems (e.g. SHAPE) as and when required
4. Create, assign and administrate actions of Trackwise / AQWA as required.
5. Act as system owner for internal QMS such as Trackwise, AQWA, SHAPE, ESOPS D2 and Up4Growth in order to manage new on-boarding of associates and assist with problem solving on QMS systems.
6. Follow-up with IT on the installation of computers / telephones for new employees.
KEY RESULT AREA 5: Assist the IPQS department with new product Launch related activates
To ensure that all company launches are executed on time and in a compliant manner
Assist the IPQS department with activities related to launch, such as:
1. Attend launch meetings and liaise with the Launch manager on important milestones
2. Assist in drafting, circulating and compiling Quality Assurance agreements
3. Prepare Product Specific Annexures for new launches or pack line extensions
4. Assist in drafting, circulating and compiling Health Authority related communications (e.g. Exemptions, Permits etc.)
KEY RESULT AREA 6: Customer Service and Business Partnering
To provide and ensure a high level of service both to internal and external customers, and to partner with departments on matters related to Quality Assurance.
1. Responding to requests adequately, satisfactorily and timeously.
2. Partnering with departments in order to provide guidance in conducting business activities in scope of QA in a compliant manner.
KEY RESPONSIBILITY AREA 1: CORPORATE GOVERNANCE
To take responsibility for Corporate Citizenship within the sphere of influence and control, and to enforce the Code of Conduct and monitor employees’ activities within the spirit of the company’s policy.
KEY RESPONSIBILITY AREA 2: ORGANISATIONAL RELATIONSHIPS
1. The IPQS Assistant reports directly to the Quality Lead (IPQS).
2. The IPQS Assistant has a functional working relationship with:
• Supply Chain
• Medical Affairs
• Marketing and Sales
KEY RESPONSIBILITY AREA 3: AUTHORITY LIMITS
Has the full authority to undertake the tasks necessary to achieve the key results of the position, provided it is within the company policies and procedures and guidelines as set down by the direct manager.
Languages: English and Afrikaans
BSc degree in related field preferred.
Minimum of 0-2 years’ experience in Quality Administration preferred.
Technical Knowledge: Computer literacy in the MS Office Suite (Intermediary and Advanced).
Professional Knowledge: General office / administrative processes and procedures. Telephone etiquette.
Soft Skills/Behaviours: Planning & organising, confidentiality, interpersonal skills, patience, ability to prioritise, attention to detail, customer focussed (internal and external), integrity and loyalty, professional work ethic, time management, results orientated.
Send your CV to Vicki@medicalcareers.co.za