Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Commercial CMC QA Specialist
8000 Marina Boulevard Suite 300 Brisbane, CA 94005 US
Posted: 02/14/2024
2024-02-14
2024-04-14
Employment Type:
Contract
Job Category: QA/Automation
Job Number: 598809
Is job remote?: Yes
Country: United States
Job Description
Pay is commiserate with experience and ranges between $35-45/hr
POSITION SUMMARY:
The Pharma Commercial CMC QA Specialist is responsible for assuring compliant release of biological prescription medicines to domestic and international markets in accordance with the applicable Marketing Authorizations and Product Dossiers on file with various regulatory bodies. In general, this includes oversight of third-party service provides, batch regard review, deviation management, compilation of release packages, compilation of Lot Release Protocols (LRP) to the FDA, and interaction with QPs and RPs in international markets.
PRIMARY RESPONSIBILITIES:
People and know-how: Flexibility with work schedule based on business need and regional requirements. Ability to work with cross-functional partners, i.e., Technical Operations, CDMO’s, Quality Control, Distribution Partners, QPs/RPs, and Regulatory Affairs.
Product Related
o Review & Approval of Master Production Records and Specifications
o Review of executed batch records, deviations, change controls.
o Batch disposition
o Resolution of production related issues
o Review and Approval or Quality Control protocols, reports, deviations
o Review and Approval of Process Validation Protocols and Reports
o Inspection readiness (CMO and Internal GMP)
o Product complaint intake from call centers and investigation
o CMO and GMP laboratory audits
o CMO and GMP laboratory Quality Agreements
o Annual Product Quality Review
o Biologic Product Deviation Report assessment
o Review of CMC related regulatory filings.
o Distribution Quality – 3PLs, transporters, importers, warehouses
Quality Systems
Assistance for the compliant state of the QMS specifically:
• Document Management and Records Retention- All related SOPs, Work Instructions, Training and Veeva tool
• Deviation, CAPA and Change Control – All related SOPs, Work Instructions, Training and Veeva tool.
• Audit program – SOPs, schedules, vendor credentials, contracts
• Training program- assist in curriculum assignment, running training KPI reports.
Assistance for Computerized System Validation Compliance
• Provide QA review and approval of validation associated with ALL GxP computer related system.
• Audit Computer Systems vendors for compliance to GAMP and Part 11/Annex 11 and data integrity
Performing analysis, creating reports, and supplying metrics to meet Stakeholder requirements.
General
o Establish and maintain effective work relationships within the department, the Company, and its global affiliates.
o Develop and maintain a culture in which quality is top priority and a spirit of continuous improvement is fostered, as well as strict awareness of company and quality goals.
o Support integration, acquisition, and new product/market activities as necessary
o Other duties as assigned.
Support during audit and inspections: Ensure necessary support during audits and inspections (FDA, MHRA, EMA, Swiss Medic, AMF, etc.)
Continuous improvement: target first time right (FTR) and Average Release Time (ART), suggest improvement of processes.
EXPERIENCE:
Academic Experience
Bachelor's in a scientific discipline or equivalent experience preferred.
Operational Experience
• Minimum of 5 years of hands-on experience in a pharmaceutical or biotechnology company
• Comprehensive working knowledge of local, state, federal, and international regulations and industry practices pertaining to GMP, GDP, and ICH guidelines.
Business Experience
• Different factory positions in Quality
• Proven track record in delivering results by working with cross-functional teams.
Other Skills
• Superior verbal and written communication, leadership and planning skills are required
• Able to understand and to clarify complex problems
• Able to identify and suggest new opportunities
• Excellent cross-functional stakeholder management skills
• Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, and MS Power Point, as well as Box and/or SharePoint
• Outstanding problem-solving capabilities
POSITION SUMMARY:
The Pharma Commercial CMC QA Specialist is responsible for assuring compliant release of biological prescription medicines to domestic and international markets in accordance with the applicable Marketing Authorizations and Product Dossiers on file with various regulatory bodies. In general, this includes oversight of third-party service provides, batch regard review, deviation management, compilation of release packages, compilation of Lot Release Protocols (LRP) to the FDA, and interaction with QPs and RPs in international markets.
PRIMARY RESPONSIBILITIES:
People and know-how: Flexibility with work schedule based on business need and regional requirements. Ability to work with cross-functional partners, i.e., Technical Operations, CDMO’s, Quality Control, Distribution Partners, QPs/RPs, and Regulatory Affairs.
Product Related
o Review & Approval of Master Production Records and Specifications
o Review of executed batch records, deviations, change controls.
o Batch disposition
o Resolution of production related issues
o Review and Approval or Quality Control protocols, reports, deviations
o Review and Approval of Process Validation Protocols and Reports
o Inspection readiness (CMO and Internal GMP)
o Product complaint intake from call centers and investigation
o CMO and GMP laboratory audits
o CMO and GMP laboratory Quality Agreements
o Annual Product Quality Review
o Biologic Product Deviation Report assessment
o Review of CMC related regulatory filings.
o Distribution Quality – 3PLs, transporters, importers, warehouses
Quality Systems
Assistance for the compliant state of the QMS specifically:
• Document Management and Records Retention- All related SOPs, Work Instructions, Training and Veeva tool
• Deviation, CAPA and Change Control – All related SOPs, Work Instructions, Training and Veeva tool.
• Audit program – SOPs, schedules, vendor credentials, contracts
• Training program- assist in curriculum assignment, running training KPI reports.
Assistance for Computerized System Validation Compliance
• Provide QA review and approval of validation associated with ALL GxP computer related system.
• Audit Computer Systems vendors for compliance to GAMP and Part 11/Annex 11 and data integrity
Performing analysis, creating reports, and supplying metrics to meet Stakeholder requirements.
General
o Establish and maintain effective work relationships within the department, the Company, and its global affiliates.
o Develop and maintain a culture in which quality is top priority and a spirit of continuous improvement is fostered, as well as strict awareness of company and quality goals.
o Support integration, acquisition, and new product/market activities as necessary
o Other duties as assigned.
Support during audit and inspections: Ensure necessary support during audits and inspections (FDA, MHRA, EMA, Swiss Medic, AMF, etc.)
Continuous improvement: target first time right (FTR) and Average Release Time (ART), suggest improvement of processes.
EXPERIENCE:
Academic Experience
Bachelor's in a scientific discipline or equivalent experience preferred.
Operational Experience
• Minimum of 5 years of hands-on experience in a pharmaceutical or biotechnology company
• Comprehensive working knowledge of local, state, federal, and international regulations and industry practices pertaining to GMP, GDP, and ICH guidelines.
Business Experience
• Different factory positions in Quality
• Proven track record in delivering results by working with cross-functional teams.
Other Skills
• Superior verbal and written communication, leadership and planning skills are required
• Able to understand and to clarify complex problems
• Able to identify and suggest new opportunities
• Excellent cross-functional stakeholder management skills
• Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, and MS Power Point, as well as Box and/or SharePoint
• Outstanding problem-solving capabilities
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