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Quality - Manager, Compliance
Manati, PR · Biotech/PharmaceuticalSummary/Overview:
This position is responsible for maintaining several elements within the Quality Systems framework to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and Client policies. Incumbent must comply with Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
RESPONSIBILITIES:
1. Must handle the entire Investigation process.
2. Acknowledge conducts and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses.
3. Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
4. Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to internal and external audits.
5. Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
Experience Required:
Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry or medical device.
Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
Strong knowledge of relevant GMP, FDA, EU regulations.
Expert in the interpretation and application of regulations according with the intended use.
Self-motivated, creative and team work oriented.
Excellent interpersonal skills and the ability to interact with people at all levels.
Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
Self-motivated, creative and team work oriented.
Education Required:
Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.
Additional Requirements:
Self-starter and good organizing and planning skills
Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise.
Strong knowledge and experience in statistical tools
Strong presentation skills
Able to exercise good judgment
Able to work under pressure
Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
Sense of urgency and analytical thinking are some of the critical competencies required for this position.
Work Environment:
• Minimum exposure to hazardous areas.
• Demands of 40% of the time sit, 30% stand and 30% walk.
• Ability to keep work pace and or meet deadlines.
• Frequent writing in English and Spanish
• Extreme attention to documentation nomenclature details, retention policy applicable and coordination are considered critical due to the variety and regulation of documents being handled.
• Special gowning as defined and required in the manufacturing and required areas. Frequent material handling between 21-35 pounds (lifting) - This is not a frequent activity.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
This position is responsible for maintaining several elements within the Quality Systems framework to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and Client policies. Incumbent must comply with Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
RESPONSIBILITIES:
1. Must handle the entire Investigation process.
2. Acknowledge conducts and/or approve investigations for Customer Complaints, External Complaints, approve Regulatory Corrective Actions and Preventive Actions (CAPA), Vendor Certification, Quality Agreements, Annual Product Review/Report for Finished Product and Systems and site licenses.
3. Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
4. Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to internal and external audits.
5. Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
Experience Required:
Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry or medical device.
Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
Strong knowledge of relevant GMP, FDA, EU regulations.
Expert in the interpretation and application of regulations according with the intended use.
Self-motivated, creative and team work oriented.
Excellent interpersonal skills and the ability to interact with people at all levels.
Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
Self-motivated, creative and team work oriented.
Education Required:
Bachelor Degree in Chemical, Engineering, Biology or Microbiology Science.
Additional Requirements:
Self-starter and good organizing and planning skills
Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise.
Strong knowledge and experience in statistical tools
Strong presentation skills
Able to exercise good judgment
Able to work under pressure
Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
Sense of urgency and analytical thinking are some of the critical competencies required for this position.
Work Environment:
• Minimum exposure to hazardous areas.
• Demands of 40% of the time sit, 30% stand and 30% walk.
• Ability to keep work pace and or meet deadlines.
• Frequent writing in English and Spanish
• Extreme attention to documentation nomenclature details, retention policy applicable and coordination are considered critical due to the variety and regulation of documents being handled.
• Special gowning as defined and required in the manufacturing and required areas. Frequent material handling between 21-35 pounds (lifting) - This is not a frequent activity.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*