Zimasa Mnyaka
Port Elizabeth
Summary
BSc Honours in Environmental Monitoring and Modelling (2018), BTech in Quality (2007), and National Diploma in Analytical Chemistry (2004). Holds certifications in Occupational Health and Safety Management System Auditing and SAMTRAC from NOSA. Possesses 20 years of experience in the Pharmaceutical Industry, currently serving as a Quality Systems Officer. Previous roles include Specification Analyst and Senior Specification and Quality Review Analyst at Aspen Pharmacare, as well as Chemical Analyst at Fresenius Kabi Manufacturing. This extensive background has developed deep expertise in specification analysis and quality management systems.
Overview
22
22
years of professional experience
Work History
Quality Systems Officer
Aspen Pharmacare
06.2023 - Current
- Implement policies and procedures
- Provide input into work activities and priorities for the unit
- Provide recommendations on improvement in processes
- Lead team in the implementation of administrative improvements
- Control of all external documents
- Maintain change control and deviation monthly log sheets; report any trends noted
- Control and maintain Signature Specimen Register and Delegation Letters
- Generate, issue, check, control and archive logbooks
- Assist with internal audits and audit report; follow up on corrective actions for close out and effectiveness
- Maintain and update the industry and regulatory standards and guidelines to ensure that facilities comply with the latest version
- Implement improvements to documentation and documentation practices
- Update written departmental SOP’s when required
- Compile and update general procedures for the facility as required
- Coordinate and manage the evaluation, collation and generation of SOPs
- Manage and improve control and support systems used for filing and recovery
- Liaise with off-site storage companies and manage on-site vs. off-site storage for the facility
- Maintain and control all Quality Systems databases and indexes
- Manage and implement the SLIMS and QMS across the laboratories in accordance with Regulatory requirements and standards
- Maintain and improve quality support to QMS
- Monitor GLP and ISO compliance of QMS and SLIMS
- Assist staff with quality documents and Reporting and record-keeping
- Maintain and update records and systems as required
- Coordinate and consolidate the gathering of information for reporting
- Compile detailed reports and documents
- Monitor and control data integrity in Quality databases
- Communicate with internal stakeholders to achieve work objectives, maintain relationships
Laboratory Quality Review Analyst
Aspen Pharmacare
04.2021 - 05.2023
- Perform LQRs according to Production plan
- Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
- Electronic approval of analytical results on relevant software. e.g. Empower
- Evaluate and interpret chromatography data to ensure accuracy of results.
- Review and approve batch documentation compliance with SOPs and quality standards
- Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
- Record all OOS investigations and conclusions, and report to management
- Provide advise to analysts during laboratory investigations.
- Provide input into SOPs
- Ensure that products are produced, tested and stored according to the required SOP’s and documentation
- Ensure adherence by Analyst/ Tester before release
Call Center Agent
WNS Global Services
09.2020 - 12.2020
- Follow clear instructions and guidelines to investigate, resolve and process high volume customer enquiries delivering customer value at first point of contact
- Identify and understand customer needs in order to provide a consistently high-quality service
- Effectively promote the client’s products and enhance customer experience and loyalty.
- Provide accurate information on products and services to ensure consistency across the organization and provide a reliable and trustworthy customer service
- Escalate any queries, complaints and operational or regulatory risks to the relevant team to ensure they are handled and resolved in a timely manner
- Ensure action is taken to increase customer retention, loyalty and build a credible reputation
- Operate customer related information systems to the required standard maintaining accurate and secure records
- Understand and adhere to the company and department standards, policies and procedures
- Adhere to procedures, in particular, to promote a culture where customers are treated fairly and are properly informed
Lims Specification Analyst
Fresenius Kabi Manufacturing
08.2018 - 12.2019
- Updating existing method of analysis
- Compilation of new method of analysis according to the pharmaceutical standards
- Evaluate and assess impact on changes regarding supplier’s COA or in case of any changes in the Pharmacopeia and internal specification
- Follow a change control procedure every time there is an update on the specification and the Pharmacopeia
Chemical Analyst
Fresenius Kabi Manufacturing
03.2018 - 07.2018
- Performing analysis on raw materials and calibration of pH
- Density meter
- Weighing balance and conductivity meter
- Report writing of the raw data
Senior Specification and Quality Review Analyst
Aspen Pharmacare
04.2007 - 04.2017
- To ensure efficient transfer of new product methods into site systems and advising on analytical work required for the effective compilation of new or amended specifications as per launch requirements
- Ensuring that the documents of each method or product are controlled and in case of any changes follow a change control procedure every time
- Advise on further analytical evaluation/ validation required for compilation of specifications/ methods.
- Liaise with laboratory buyer on purchase of new reagents, standards, columns, consumables required
- Identify and issue new item numbers
- Compile and review methods prior to implementation.
- Perform analysis of samples (when required) to support compilation of new analytical methods, or support specification changes /updates
- Compiling reports of analytical data generated
- Accurately interpret and calculate results
- Provide detail observations from the analysis of data and interpretation of results
- Assist in solving all related analytical problems experienced
- Perform quality review of analytical data according to schedule
- Verify the correctness and accuracy of analytical results, including HPLC and GC analysis
- Ensure that all queries are actioned by relevant laboratory personnel
- Ensure that all OOS investigations are executed and completed as required (including calibration and maintenance)
- Report all OOS’s to relevant Line Management and assist in OOS data trends
- Investigate and initiate corrective actions for all quality deficiencies
- Provide feedback on daily schedules to Section Head
- (Pharmaceutical)
SHE Representative
Aspen Pharmacare
- Volunteered as a Safety Rep doing monthly checks
- Safety talks
- Involved in identifying hazardous chemicals
- (General Facility and SVP)
Specification Analyst
Aspen Pharmacare
05.2004 - 04.2007
- Performing analysis on purified water daily
- Updating the specification methods and performing analytical method on new products and raw materials
- Compiling reports of analytical data and draft specification methods
- (General Facility)
Trainee Student
Port Elizabeth Technikon
01.2004 - 04.2004
- Laboratory technician and student assistant
Education
Grade 12 -
Ntsonkotha Senior Secondary School
QueenstownBSc Honours - Environmental Monitoring and Modelling
UNISA
02.2018
BTech - Quality
Nelson Mandela Metropolitan University
01.2007
National Diploma - Analytical Chemistry
Port Elizabeth Technikon
01.2004
Certificate in SAMTRAC - undefined
NOSA
01.2014
Certificate in Occupational Health Safety Management Systems Auditing Based on BS OHSAS 18001:2007, ISO 19011 and ISO 17021(SABS) - undefined
12.2017
Certificate in Understanding and Implementation of OHS Management Systems Based on BS OHSAS 18001:2007 – (SABS) - undefined
10.2017
Skills
Critical thinking skills
Skills Highlights
- Critical thinking skills
- Problem solving
- Self-management skills
- Detail oriented
- Creative
- Communication skills
- Data Integrity
References
- Miss B. Melitafa, Supervisor, Fresenius Kabi Manufacturing, 083 535 2209
- Miss. M Sibanda, Team Leader, Aspen Pharmacare, 076 211 9308 / 043 705 7082
- Mr M Konyase, Aspen Pharmacare, 069 357 7756 / 078 279 8205
Timeline
Quality Systems Officer
Aspen Pharmacare
06.2023 - Current
Laboratory Quality Review Analyst
Aspen Pharmacare
04.2021 - 05.2023
Call Center Agent
WNS Global Services
09.2020 - 12.2020
Lims Specification Analyst
Fresenius Kabi Manufacturing
08.2018 - 12.2019
Chemical Analyst
Fresenius Kabi Manufacturing
03.2018 - 07.2018
Senior Specification and Quality Review Analyst
Aspen Pharmacare
04.2007 - 04.2017
Specification Analyst
Aspen Pharmacare
05.2004 - 04.2007
Trainee Student
Port Elizabeth Technikon
01.2004 - 04.2004
SHE Representative
Aspen Pharmacare
BSc Honours - Environmental Monitoring and Modelling
UNISA
BTech - Quality
Nelson Mandela Metropolitan University
National Diploma - Analytical Chemistry
Port Elizabeth Technikon
Certificate in SAMTRAC - undefined
NOSA
Certificate in Occupational Health Safety Management Systems Auditing Based on BS OHSAS 18001:2007, ISO 19011 and ISO 17021(SABS) - undefined
Certificate in Understanding and Implementation of OHS Management Systems Based on BS OHSAS 18001:2007 – (SABS) - undefined
Grade 12 -
Ntsonkotha Senior Secondary School