Quality Assurance Specialist
Share
Job Location:
Monthly Salary:
Posted on:
12 days ago
Vacancies:
1 Vacancy
Job Summary
Position Overview
We are seeking an experienced Quality Assurance Specialist to join our pharmaceutical manufacturing team. This role requires a technical professional with deep expertise in GMP compliance computerized systems validation and pharmaceutical quality operations.
Key Responsibilities
- Ensure compliance with FDA GMP 21 CFR Part 11 EU regulations and Data Integrity requirements
- Conduct risk assessments and data mapping activities
- Lead and support computerized systems validation initiatives using GAMP5 methodology
- Review and approve validation/commissioning and technical documentation
- Collaborate with cross-functional teams to maintain quality standards
- Utilize quality management systems (TrackWise/Infinity) and enterprise software (SAP)
- Support investigations CAPAs and continuous improvement initiatives
- Provide technical guidance and recommendations on quality matters
Required Qualifications
Education
- Bachelors degree in science (Chemical Engineering Engineering Biology Pharmacy or Microbiology)
Experience
- Minimum 6 years of Quality Assurance experience in the pharmaceutical industry
- Proven background in pharmaceutical products manufacturing environment
- Hands-on experience with computerized systems validation
- Proven background in pharmaceutical products manufacturing environment
- Hands-on experience with computerized systems validation
Language Requirements
- **Fully bilingual (Spanish/English)** - written and verbal communication required
Core Competencies
- Self-motivated with strong initiative and creative problem-solving abilities
- Team-oriented with excellent interpersonal skills
- Technical and scientific capability to make firm decisions and recommendations
- Effective communication skills across all organizational levels
- Strong sense of urgency and analytical thinking
- Ability to work irregular hours rotative shifts weekends and holidays when needed
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
We are seeking an experienced Quality Assurance Specialist to join our pharmaceutical manufacturing team. This role requires a technical professional with deep expertise in GMP compliance computerized systems validation and pharmaceutical quality operations.
Key Responsibilities
- Ensure compliance with FDA GMP 21 CFR Part 11 EU regulations and Data Integrity requirements
- Conduct risk assessments and data mapping activities
- Lead and support computerized systems validation initiatives using GAMP5 methodology
- Review and approve validation/commissioning and technical documentation
- Collaborate with cross-functional teams to maintain quality standards
- Utilize quality management systems (TrackWise/Infinity) and enterprise software (SAP)
- Support investigations CAPAs and continuous improvement initiatives
- Provide technical guidance and recommendations on quality matters
Required Qualifications
Education
- Bachelors degree in science (Chemical Engineering Engineering Biology Pharmacy or Microbiology)
Experience
- Minimum 6 years of Quality Assurance experience in the pharmaceutical industry
- Proven background in pharmaceutical products manufacturing environment
- Hands-on experience with computerized systems validation
- Proven background in pharmaceutical products manufacturing environment
- Hands-on experience with computerized systems validation
Language Requirements
- **Fully bilingual (Spanish/English)** - written and verbal communication required
Core Competencies
- Self-motivated with strong initiative and creative problem-solving abilities
- Team-oriented with excellent interpersonal skills
- Technical and scientific capability to make firm decisions and recommendations
- Effective communication skills across all organizational levels
- Strong sense of urgency and analytical thinking
- Ability to work irregular hours rotative shifts weekends and holidays when needed
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
Required Experience:
IC
Key Skills
- Invoicing
- Information Technology Sales
- IT Support
- Audio Visual
- Database Administration
About Company
Joomla template for company and business - JA Company built with T3 Framework, fully responsive and integrates JA page Builder
