![PSC Biotech Ltd](https://media.trabajo.org/img/noimg.jpg)
Manufacturing Specialist
2 weeks ago
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Description:
The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge.
Requirements
Role responsibilities:
· Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings.
· Clear and concise technical writing of complex investigations
· Drive improvements to the investigation process
· Present investigations to regulatory inspectors and internal auditors
· Clearly communicate investigation progress to impacted areas and leadership
· Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
· Project management of the investigations end to end
· Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
· Build effective relationships across functions.
· Navigate through ambiguity and provide a structured problem-solving approach.
· Able to apply inductive and deductive reasoning in the investigation process
Qualifications:
· Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
· Detailed technical understanding of fill/finish operations
· Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
· Experience leading complex investigations
· Experience participating in and leading cross-functional teams
· Experience in managing multiple, competing priorities in a fast-paced environment
· Experience presenting to inspectors during regulatory inspections and internal audits.
· Excellent technical writing
· Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
· Ability to be flexible and manage change
#LI-KV1
Requirements
Role responsibilities: · Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings. · Clear and concise technical writing of complex investigations · Drive improvements to the investigation process · Present investigations to regulatory inspectors and internal auditors · Clearly communicate investigation progress to impacted areas and leadership · Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule. · Project management of the investigations end to end · Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues. · Build effective relationships across functions. · Navigate through ambiguity and provide a structured problem-solving approach. · Able to apply inductive and deductive reasoning in the investigation process Qualifications: · Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment · Detailed technical understanding of fill/finish operations · Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems. · Experience leading complex investigations · Experience participating in and leading cross-functional teams · Experience in managing multiple, competing priorities in a fast-paced environment · Experience presenting to inspectors during regulatory inspections and internal audits. · Excellent technical writing · Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff · Ability to be flexible and manage change #LI-KV1
-
Manufacturing Specialist
5 days ago
India PSC Biotech Ltd Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Technical Operations
1 month ago
india PSC Biotech Ltd Full timeJob Description About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Purchasing Specialist
5 days ago
India Agensi Pekerjaan BTC Sdn Bhd Full timeJob Description Open Position: Purchasing Specialist (MNC Food Packaging Company) An MNC Food Packaging Company is looking for Purchasing Specialist to lead purchasing and negotiation activities and be based in the Selangor office.Key requirements include: Responsible for all activities of purchasing including negotiation and managing raw materials on...
-
Validation Specialist
5 days ago
India QRC Group, LLC Full timeJob Description Validation Specialist with experience in regulated industry, validating/qualifying laboratory equipment, manufacturing equipment, processes, utilities and facilities.Tasks: Execute complete validation cycleChange ControlEquipment qualification (manufacturing and laboratory) Requirements Bachelor in Engineering or SciencesAt least five years...
-
Validation Specialist
2 months ago
india QRC Group, LLC Full timeJob Description Validation Specialist with experience in regulated industry, validating/qualifying laboratory equipment, manufacturing equipment, processes, utilities and facilities.Tasks: Execute complete validation cycleChange ControlEquipment qualification (manufacturing and laboratory) Requirements Bachelor in Engineering or SciencesAt least five years...
-
Investigations Specialist
5 days ago
India QRC Group, LLC Full timeJob Description Investigations Specialist with experience in regulated industries. Strong knowledge of complaints and processes deviations. Will be responsible for performing through, detailed and timely investigations and generation of high quality and timely investigation reports.Responsibilities: Understanding of the investigation process as it applies...
-
Investigations Specialist
2 months ago
india QRC Group, LLC Full timeJob Description Investigations Specialist with experience in regulated industries. Strong knowledge of complaints and processes deviations. Will be responsible for performing through, detailed and timely investigations and generation of high quality and timely investigation reports.Responsibilities: Understanding of the investigation process as it applies...
-
Investigations Specialist
4 weeks ago
india QRC Group, LLC Full timeJob Description Investigations Specialist with experience in regulated industries. Strong knowledge of complaints and processes deviations. Will be responsible for performing through, detailed and timely investigations and generation of high quality and timely investigation reports.Responsibilities: Understanding of the investigation process as it applies...
-
Sales Specialist
5 days ago
India GreeneStep Technologies Full timeCompany Description Embark on a digital transformation journey with GreeneStep Next-Gen Business Automation Solutions. GreeneStep is a powerhouse of business innovation, offering a dynamic suite of products including ERP, CRM, Workforce & Projects Collaboration, Ecommerce Webstore, Financials, Accounting, Retail Point-of-Sales, IT Assets Management,...
-
Training Specialist
5 days ago
India Agensi Pekerjaan BTC Sdn Bhd Full timeJob Description Open Position: Training Specialist (MNC Company) A reputable Company is currently looking for a Training Specialist to join the team and be based in the Selangor office. Key responsibilities include: More than 5 years of experience as trainer, external training specialist in Engineering/Manufacturing related products Demonstrated experience...
-
Technical Sales Specialist
6 days ago
india Cold Box Solutions Full timeCompany Description Cold Box Solutions is a dynamic startup headquartered in Odisha, specializing in "Deep Cryogenic Treatment". Our goal is to deliver highly effective solutions to manufacturing plants, empowering them to boost productivity and streamline operations. Leveraging proven technologies and state-of-the-art infrastructure, our innovative...
-
Telesales Specialist
4 weeks ago
india PALMIST HEALTHCARE PRIVATE LIMITED Full timeCompany Description Welcome to Palmist Healthcare Pvt. Ltd, a company based in New Delhi that offers top-quality skincare and haircare solutions. We provide a range of specialized services including private labelling, third-party manufacturing, custom formulation, legal assistance, and drop shipping. With our expertise and cutting-edge facilities, we empower...
-
Telesales Specialist
5 days ago
India PALMIST HEALTHCARE PRIVATE LIMITED Full timeCompany Description Welcome to Palmist Healthcare Pvt. Ltd, a company based in New Delhi that offers top-quality skincare and haircare solutions. We provide a range of specialized services including private labelling, third-party manufacturing, custom formulation, legal assistance, and drop shipping. With our expertise and cutting-edge facilities, we empower...
-
Quality Assurance Specialist
3 weeks ago
india Indsource International Full timeCompany Description Indsource International is a leading Buying House based in Gurugram, India. We specialize in home, lifestyle, and fashion products including softlines such as textiles for home, bath, kitchen, and floor, as well as hardgoods like handicrafts, lamps, furniture, and decoratives in various materials. We ensure a smooth and buyer-friendly...
-
Associate Specialist
1 month ago
india PSC Biotech Ltd Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...
-
Associate Specialist
5 days ago
India PSC Biotech Ltd Full timeJob Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Investigations Specialist
3 weeks ago
india QRC Group, LLC Full timeJob Description Investigations Specialist with experience in regulated industries. Strong knowledge in Quality Notification, Complaints and Processing Deviations. Will be responsible for performing through, detailed and timely investigations and generation of high quality and timely investigation reports.Responsibilities: Understanding of the...
-
Training Specialist
1 month ago
india Agensi Pekerjaan BTC Sdn Bhd Full timeJob Description Open Position: Training Specialist (MNC Company) A reputable Company is currently looking for a Training Specialist to join the team and be based in the Selangor office. Key responsibilities include: More than 5 years of experience as trainer, external training specialist in Engineering/Manufacturing related products Demonstrated experience...
-
Sr. Quality Documentation Specialist
3 weeks ago
india QRC Group, LLC Full timeJob Description Sr Quality Documentation Specialist with experience in Technology Transfer of Regulatory Documentation such as, but not limited:Batch RecordManufacturing InstructionsSOPcGMPPreventive Maintenance Coordinate meetings with manufacturing area to ensure actual day-to-day operations fluent documentation are in accordance with cGMP. Requirements...
-
Sr Quality Documentation Specialist
2 months ago
india QRC Group, LLC Full timeJob Description Sr Quality Documentation Specialist with experience in Technology Transfer of Regulatory Documentation such as, but not limited:Batch RecordManufacturing InstructionsSOPcGMPPreventive Maintenance Coordinate meetings with manufacturing area to ensure actual day-to-day operations fluent documentation are in accordance with cGMP. Requirements...