Pilot Plant QA Specialist (QMS) Lead
About the position
The Quality Assurance (QMS) Production Lead at Cipla USA is a pivotal role responsible for ensuring that product quality is maintained throughout all phases of the manufacturing process. This position is integral to the InvaGen Pharmaceuticals Quality team and reports directly to the Quality Assurance Manager. The primary purpose of this role is to monitor compliance with established specifications and standard operating procedures (SOPs), while also providing guidance to Quality Assurance associates. The Quality Assurance Production Lead will engage in various activities, including the review of batch manufacturing and packaging records, the release of raw materials and finished products, and the oversight of engineering records such as temperature and humidity calibrations, preventive maintenance, and pest control records. In addition to these responsibilities, the Lead will review and approve non-conformance reports, change controls, deviation investigations, and corrective and preventive actions (CAPAs). They will also be responsible for reviewing and approving manufacturing and engineering qualification documents. The role requires providing daily and weekly updates to the shop floor and management regarding quality highlights and concerns, as well as creating lessons learned for training purposes. The Lead will oversee the daily activities of manufacturing quality associates, including assigning weekly work schedules and performing training and onboarding of QA associates to ensure they are qualified for their roles. This position acts as the quality lead for all shop floor questions and concerns and serves as a backup for shop floor QA associates as needed. The Quality Assurance Production Lead must possess a strong educational background, ideally with a Bachelor's degree in pharmaceutical manufacturing or a related field, and a minimum of five years of experience in quality assurance within a cGMP pharmaceutical manufacturing environment. The role demands a comprehensive understanding of the machines used in pharmaceutical manufacturing, effective interpersonal skills, and the ability to conduct troubleshooting and root cause analysis. Proficiency in computer skills, particularly with Microsoft Office and SAP, is essential, along with a preference for experience in inhalation products. The position requires a self-starter who can work in a fast-paced environment and handle multiple tasks simultaneously, demonstrating excellent organizational skills and attention to detail.
Responsibilities
• Review batch manufacturing and packaging records.
,
• Release raw materials, packaging materials, and finished products through approval of respective Certificates of Analysis (COA).
,
• Review engineering records such as temperature and humidity data calibrations, preventive maintenance records, and pest control records.
,
• Review and approve manufacturing and engineering non-conformance reports.
,
• Review and approve manufacturing and engineering change controls, deviation investigations, and CAPAs.
,
• Review and approve manufacturing and engineering qualification documents.
,
• Provide daily and weekly updates to the shop floor and management regarding quality highlights and concerns.
,
• Create lessons learned for training as a communication mechanism to shop floor personnel.
,
• Lead manufacturing quality associates on daily activities, including the assignment of weekly work schedules.
,
• Perform training and onboarding of QA associates to ensure they are qualified prior to beginning their daily functions.
,
• Act as quality lead for all shop floor questions and concerns.
,
• Act as backup for shop floor QA associates.
,
• Perform other duties as assigned by the department head.
Requirements
• Bachelor's degree in pharmaceutical manufacturing, industrial management, or a related field from an accredited college/university.
,
• Master's degree in pharmaceutical manufacturing, industrial management, or a related field is preferred.
,
• Minimum of five years' experience in quality assurance in a cGMP pharmaceutical manufacturing environment.
,
• Understanding of machines used in pharmaceutical manufacturing.
,
• Ability to influence decision making and facilitate completion of work towards business goals.
,
• Effective interpersonal relationship skills and ability to work in a team environment.
,
• Capable of conducting troubleshooting, investigations, and root cause identification and analysis.
,
• Experience handling compliance and regulatory audits at local and federal levels.
,
• Proficient in computer skills and software applications such as Microsoft Office tools.
,
• Experience using SAP business system and applications is a plus.
,
• Experience in inhalation products (MDI) is a plus.
Nice-to-haves
• Knowledge of good manufacturing practices and good documentation practices.
,
• Proficiently speak English as a first or second language.
Benefits
• Relocation negotiable.
,
• Participation in a bonus program based on performance and company results.
Apply Now
The Quality Assurance (QMS) Production Lead at Cipla USA is a pivotal role responsible for ensuring that product quality is maintained throughout all phases of the manufacturing process. This position is integral to the InvaGen Pharmaceuticals Quality team and reports directly to the Quality Assurance Manager. The primary purpose of this role is to monitor compliance with established specifications and standard operating procedures (SOPs), while also providing guidance to Quality Assurance associates. The Quality Assurance Production Lead will engage in various activities, including the review of batch manufacturing and packaging records, the release of raw materials and finished products, and the oversight of engineering records such as temperature and humidity calibrations, preventive maintenance, and pest control records. In addition to these responsibilities, the Lead will review and approve non-conformance reports, change controls, deviation investigations, and corrective and preventive actions (CAPAs). They will also be responsible for reviewing and approving manufacturing and engineering qualification documents. The role requires providing daily and weekly updates to the shop floor and management regarding quality highlights and concerns, as well as creating lessons learned for training purposes. The Lead will oversee the daily activities of manufacturing quality associates, including assigning weekly work schedules and performing training and onboarding of QA associates to ensure they are qualified for their roles. This position acts as the quality lead for all shop floor questions and concerns and serves as a backup for shop floor QA associates as needed. The Quality Assurance Production Lead must possess a strong educational background, ideally with a Bachelor's degree in pharmaceutical manufacturing or a related field, and a minimum of five years of experience in quality assurance within a cGMP pharmaceutical manufacturing environment. The role demands a comprehensive understanding of the machines used in pharmaceutical manufacturing, effective interpersonal skills, and the ability to conduct troubleshooting and root cause analysis. Proficiency in computer skills, particularly with Microsoft Office and SAP, is essential, along with a preference for experience in inhalation products. The position requires a self-starter who can work in a fast-paced environment and handle multiple tasks simultaneously, demonstrating excellent organizational skills and attention to detail.
Responsibilities
• Review batch manufacturing and packaging records.
,
• Release raw materials, packaging materials, and finished products through approval of respective Certificates of Analysis (COA).
,
• Review engineering records such as temperature and humidity data calibrations, preventive maintenance records, and pest control records.
,
• Review and approve manufacturing and engineering non-conformance reports.
,
• Review and approve manufacturing and engineering change controls, deviation investigations, and CAPAs.
,
• Review and approve manufacturing and engineering qualification documents.
,
• Provide daily and weekly updates to the shop floor and management regarding quality highlights and concerns.
,
• Create lessons learned for training as a communication mechanism to shop floor personnel.
,
• Lead manufacturing quality associates on daily activities, including the assignment of weekly work schedules.
,
• Perform training and onboarding of QA associates to ensure they are qualified prior to beginning their daily functions.
,
• Act as quality lead for all shop floor questions and concerns.
,
• Act as backup for shop floor QA associates.
,
• Perform other duties as assigned by the department head.
Requirements
• Bachelor's degree in pharmaceutical manufacturing, industrial management, or a related field from an accredited college/university.
,
• Master's degree in pharmaceutical manufacturing, industrial management, or a related field is preferred.
,
• Minimum of five years' experience in quality assurance in a cGMP pharmaceutical manufacturing environment.
,
• Understanding of machines used in pharmaceutical manufacturing.
,
• Ability to influence decision making and facilitate completion of work towards business goals.
,
• Effective interpersonal relationship skills and ability to work in a team environment.
,
• Capable of conducting troubleshooting, investigations, and root cause identification and analysis.
,
• Experience handling compliance and regulatory audits at local and federal levels.
,
• Proficient in computer skills and software applications such as Microsoft Office tools.
,
• Experience using SAP business system and applications is a plus.
,
• Experience in inhalation products (MDI) is a plus.
Nice-to-haves
• Knowledge of good manufacturing practices and good documentation practices.
,
• Proficiently speak English as a first or second language.
Benefits
• Relocation negotiable.
,
• Participation in a bonus program based on performance and company results.
Apply Now