Quality assurance associate

PROFILE

Accomplished Quality Assurance Associate professional with more than three years’ successful experience in pharmaceutical industry focusing on cGMP, SOPs, HACCP, ISO 9001, ISO 22000, QMS, CAPA. Seeking to pursue a career in pharmaceutical industries in the same role.

DEMONSTRATED SKILLS

QUALITY ASSURANCE

Extensive knowledge about quality assurance principles and measures

Strong understanding of ISO, Quality protocols, QMS, Risk management, Root cause analysis, Raw material evaluation, Quality audits (internal and external) CAPA and HACCP.

Implemented ISO 9001,22000 to the workplace.

Worked on Supplier Quality agreements, customer complaints, Batch Records, principles of GMP and GDP with an understanding of different SOPs

Other skills

• Excellent Communication and interpersonal skills with internal and external stake holders.
• Ability to work autonomously with minimal supervision.
• Good report writing skills with proven ability to review and analyse technical information.
• Ability to work under pressure, prioritise competing demands and meet deadlines.
• Profound ability to work individually and in a team. 
• Confidence to face any challenging tasks.
• Computer skills (MS Office Word and Excel, Power Point).
• Demonstrative initiative, independence and organisational skills.
• Attention to detail and able to multitask.
• Honest and reliable.
• Patience and ability to remain calm in stressful situation.
• Experienced in Customer service. 
• Flexible and open to change in wok environment.
• Analytical skills
• Driver’s license

PROJECTS

• During a contract at Catalent I worked on a project to update all the Suppliers agreements which were pending and brought about all the changes as per requirement.
• At the same time, I coordinated with all departments of Quality compliance (CAPA, Deviation, SQM, change control) to convert their track wise system into a new system named Intelex and also prepared work instructions for training purpose.

PROFESSIONAL EXPERIENCE

March 2012-Feb 2015

Quality assurance Technician

Global Pharmaceuticals PTY LTD

Key Responsibilities

• Maintaining QMS Documentation
• Identifying critical control points, monitoring CAPA and deviation procedures
• Reviewing and updating SOPs, Deviations and product Quality reviews
• Updating Supplier Quality Agreements
• Providing regular feedback to the management team about quality assurance documentation 
• Internal Audits
• Ensuring that all products batches are released in compliance with quality standards, Quality agreements and regulatory GMP
• Investigating and reporting about customer complaints
• Ensuring GMPS are maintained
• Inspection of Raw materials
• RO Water 

July 2019-Dec 2019

Quality Assurance/Compliance associate (contract)

Blackmores/Catalent Pharma Solutions, Governors Road, Braeside, Victoria

Pharmaceutical products wholesalers and manufacturers

Key Responsibilities

• Maintaining all controlled QMS documents and forms.
• Update SOPs. 
• Perform Root Cause Analysis to compute the reason behind inefficiencies.
• Work and update on Suppliers Quality agreements as Per GMP and GDP.
• Work on risk management process to help prepare for the unforeseen, identify and mitigate risks.
• Work on handling Customer complaints and CAPA.
• Raw material evaluation.
• Maintain records on Intelex
• Preparing Certificate of Analysis
• PQR Maintenance
• Preparing annual performance reports for suppliers
• Retention Samples
• Raw material Evaluation
• Change control (Hands on training)

LOCAL EXPERIENCE

April 2018-May 2019

Telemarketer

Recycle Global IT

Key Responsibilities

• Telephonic call to various schools about recycling computers
• Assisting clients in friendly and respectful manner
• Responsible for telephone enquiries about the company products and servicing
• Processing bookings and orders within time frame
• Maintaining and updating records of all customers interactions

March 2016-Feb 2018

Sales Assistant

Hemley Store South Yarra

Key Responsibilities

• Ensuring the smooth running of the store as valued team member, maintained and arranging pricing
• Merchandising and cash handling with POS system
• Answer customer queries and complaints
• Providing customers with friendly service
• Working in socially diverse environment
• Working cooperatively in a team environment
• Ensured all space in store was effectively utilised by organising a fast turnaround merchandising concepts, implementing weekly changes in store
• Ability to meet sales targets

• Identifying and resolving issues

EDUCATION

2009-2012 Master’s in business administration (Allamah Iqbal University, Islamabad, Pakistan)

Major in Management and HR

2008-2009 Diploma in Information Technology (Jinnah institute of Technology, Rawalpindi Islamabad)

2005-2007 Bachelor’s in science (Govt Post Graduate college Satellite Town Rawalpindi, Pakistan)

Major in Botany, Zoology and Chemistry

Professional Training(Catalent)

GMP and SOP Training

CAPA Training

Supplier Quality Management

Root Cause Analysis

Handling Retention sample

Water testing

Supplier Audit program

Risk Assessment

Customer Complaints

Raw Material Evaluation

ISO 22000

ISO 9001,2015

Professional Development

2019 Occupational qualification Professional Program

Melbourne Polytechnic Prahran, Vic

Major studies: Australian Management concepts, Team Communication, OHS and QA

REFERENCES

will be provided on request