Salma Muhammad
Melbourne,VIC
Summary
A punctual and motivated individual had experience in both public sector and private sector. Able to work in a busy environment and produce high standards of work. Excellent team worker and able to take instructions from all levels and build up good working relationships with all colleagues. Flexible, reliable and possess excellent time keeping skills.
Overview
5
5
years of professional experience
Work History
Assistant Quality Assurance Associate
Derma Pride Industry (Pvt)|Ltd
10.2019 - 11.2022
- Demonstrated attention to detail, analytical thinking, and the ability to establish and maintain priorities in the context of quality assurance.
- Evaluated incoming materials for quality and amounts ordered.
- Reworked positions and workflow based on individual abilities and work targets.
- Established clear priorities and quality standards.
- Developed stability protocol and reports.
- Set and revised production schedules to meet changing demands.
- Conducted thorough evaluations of incoming materials to ensure their quality and quantity met the required standards for validation purposes.
- Analyzed and reworked positions and workflows within the validation process based on individual abilities and work targets, optimizing efficiency and effectiveness.
- · Established clear priorities and quality standards to guide the validation activities and ensure compliance with regulatory requirements and industry best practices.
- Developed stability protocols and generated comprehensive reports to assess the reliability and shelf-life of products, providing valuable insights for decision-making and quality enhancement.
- Collaborated with cross-functional teams to set and revise production schedules, accommodating changing demands while maintaining the highest quality standards.
- Drafting and finalizing quality assurance policies and procedures.
- Reviewing of master batch record, label approvals and validation documentation.
- Maintaining change control, deviations and CAPA’s.
- Documenting internal audits and support on-site audits done by external providers.
- Strong knowledge on GMP.
- Fond of eQMS.
Regulatory Affairs Officer:
Wilshire Laboratories (Pvt)Ltd
02.2018 - 08.2020
- Responsible for preparing and submitting regulatory documents for product approval, such as New Drug Applications (NDAs) or Marketing Authorization Applications (MAAs).
- Interacted with regulatory agencies to address queries and provide requested information.
- Ensuresdthat product labeling, packaging, and promotional materials adhere to regulatory requirements.
- updated with changes in regulations and guidelines to ensure compliance.
- Ensuring product quality and regulatory compliance in manufacturing and quality control processes.
- Conducted audits and inspections to verify compliance with Good Manufacturing Practices (GMP) and other regulations.
- Collaborated with regulatory affairs to align quality systems with regulatory requirements.
Internee Production Pharmacist
Rehaman Rainbow
02.2018 - 07.2018
- Ensured compliance to Good Manufacturing Practices (GMP)
- Monitored machine operation and environmental stability and sterilization chambers.
- Performed preventative maintenance to maintain optimal productivity.
Education
Doctor of Pharmacy - Pharmacy
Hajvery University
Lahore,Punjab 2018
Skills
- Ability to engage people
- Effective Communication
- Time management
- Computer proficient
- Record keeping strengths
- Decision-making
- Supply chain management
- Report writing
- Microsoft applications skills
Timeline
Assistant Quality Assurance Associate
Derma Pride Industry (Pvt)|Ltd
10.2019 - 11.2022
Regulatory Affairs Officer:
Wilshire Laboratories (Pvt)Ltd
02.2018 - 08.2020
Internee Production Pharmacist
Rehaman Rainbow
02.2018 - 07.2018
Doctor of Pharmacy - Pharmacy
Hajvery University
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