SUN PHARMA
Join to apply for the
QC Head
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SUN PHARMA Join to apply for the
QC Head
role at
SUN PHARMA Job Summary
Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.
Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures. Job Summary
Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures.
Area Of Responsibility
Execute and review analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, ISO Quality Assurance Procedures, SOPs and established deadlines Establish and maintain a comprehensive QC training program for analytical personnel and reinforce the training with appropriate assignment(s) and delegation of responsibility Monitor and prepare formal evaluations of employee performance to ensure continued compliance Ensure safe operations in the laboratory Coordinate transfer of methods (new/alternate, customer supplied (ILQ) or improved methods) or technology (instruments) into the QC laboratory Train QC analysts on new/improved instruments and test methods Identify, procure, install and qualify required QC instrumentation and equipment Establish and maintain laboratory programs to monitor and evaluate systems or equipment (i.e. analytical instrument and equipment, etc.) status, ensure efficient laboratory performance and compliance with preventive maintenance, qualification, and calibration schedules Establish and maintain laboratory programs to process, monitor and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput Oversee and allocate personnel required to ensure deadlines are met Direct and close all QC Stage 1 OOS investigations, deviations, CAPA, and QA investigations within established target dates Oversee and continuous improvement of FDA compliant Quality System Manage the team including mentoring and coaching of staff, establishing priorities, and delivering projects within budget and on time Use a team-oriented approach to problem resolution Other duties as assigned
Work Conditions
Office Lab Controlled area/clean room Exposure to noise, heat, open flame and radiation in certain areas Exposure to non-hazardous and hazardous chemicals, toxic metals (arsenic, lead, and mercury) Cryogenic gases (LN 2) and radioactive materials Requires access/work in chemical fume hoods Exposure to/use of syringes and needles
Experience
Minimum 6-8 years related experience with minimum 0-2 years related experience in a supervisory role preferred Comprehensive knowledge of wet chemical and instrumental analysis methods, including method development and validation Proficient verbal, written and interpersonal communication skills Excellent supervisory skills Ability to work with minimal supervision Strong chemistry theory skills Strong organization skills Position requires a balance between administrative (office) duties and laboratory work Understanding of cGMP, GLPs and ISO requirements Computer literacy/proficiency; PC with spreadsheet and or instrument control software Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at SUN PHARMA by 2x Sign in to set job alerts for “Head of Quality Control” roles.Associate Director / Director, Quality ControlDirector/Sr. Director, Quality Systems and GxP Compliance Boston, MA $175,000.00-$200,000.00 2 days ago Head of Analytical Development & Quality Control Waltham, MA $218,000.00-$300,000.00 1 week ago Head of Quality Assurance & Regulatory AffairsAssociate Director, Quality Control - StabiliSenior Director, Analytical Development/Quality ControlHead of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Head of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Head of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Associate Director, Analytical Development & QC Boston, MA $169,000.00-$194,000.00 2 weeks ago Associate Director, Analytical Development & QC Boston, MA $169,000.00-$194,000.00 2 weeks ago Customer Success Manager: Consumer Packaged Goods (CPG)QC Supervisor, Microbiology (2nd Shift, 1pm-9:30pm)Prepared Meals and Rotisserie Chicken AssociateFreezer, Cooler and Deli Stocker AssociateMedical Assistant - Pediatrics - 4.5 days/weekMedical Assistant - 4.5 days/week - Internal Medicine We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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QC Head
role at
SUN PHARMA Join to apply for the
QC Head
role at
SUN PHARMA Job Summary
Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.
Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures. Job Summary
Supervise the Quality Control Laboratory activities and personnel, ensuring compliance is maintained with cGMP, ISO, GLPs and company policies and procedures.
Area Of Responsibility
Execute and review analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, ISO Quality Assurance Procedures, SOPs and established deadlines Establish and maintain a comprehensive QC training program for analytical personnel and reinforce the training with appropriate assignment(s) and delegation of responsibility Monitor and prepare formal evaluations of employee performance to ensure continued compliance Ensure safe operations in the laboratory Coordinate transfer of methods (new/alternate, customer supplied (ILQ) or improved methods) or technology (instruments) into the QC laboratory Train QC analysts on new/improved instruments and test methods Identify, procure, install and qualify required QC instrumentation and equipment Establish and maintain laboratory programs to monitor and evaluate systems or equipment (i.e. analytical instrument and equipment, etc.) status, ensure efficient laboratory performance and compliance with preventive maintenance, qualification, and calibration schedules Establish and maintain laboratory programs to process, monitor and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput Oversee and allocate personnel required to ensure deadlines are met Direct and close all QC Stage 1 OOS investigations, deviations, CAPA, and QA investigations within established target dates Oversee and continuous improvement of FDA compliant Quality System Manage the team including mentoring and coaching of staff, establishing priorities, and delivering projects within budget and on time Use a team-oriented approach to problem resolution Other duties as assigned
Work Conditions
Office Lab Controlled area/clean room Exposure to noise, heat, open flame and radiation in certain areas Exposure to non-hazardous and hazardous chemicals, toxic metals (arsenic, lead, and mercury) Cryogenic gases (LN 2) and radioactive materials Requires access/work in chemical fume hoods Exposure to/use of syringes and needles
Experience
Minimum 6-8 years related experience with minimum 0-2 years related experience in a supervisory role preferred Comprehensive knowledge of wet chemical and instrumental analysis methods, including method development and validation Proficient verbal, written and interpersonal communication skills Excellent supervisory skills Ability to work with minimal supervision Strong chemistry theory skills Strong organization skills Position requires a balance between administrative (office) duties and laboratory work Understanding of cGMP, GLPs and ISO requirements Computer literacy/proficiency; PC with spreadsheet and or instrument control software Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at SUN PHARMA by 2x Sign in to set job alerts for “Head of Quality Control” roles.Associate Director / Director, Quality ControlDirector/Sr. Director, Quality Systems and GxP Compliance Boston, MA $175,000.00-$200,000.00 2 days ago Head of Analytical Development & Quality Control Waltham, MA $218,000.00-$300,000.00 1 week ago Head of Quality Assurance & Regulatory AffairsAssociate Director, Quality Control - StabiliSenior Director, Analytical Development/Quality ControlHead of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Head of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Head of Product Quality & Lifecycle Management, Biologics Operating Unit (Sr Director) Lexington, MA $208,200.00-$327,140.00 1 week ago Associate Director, Analytical Development & QC Boston, MA $169,000.00-$194,000.00 2 weeks ago Associate Director, Analytical Development & QC Boston, MA $169,000.00-$194,000.00 2 weeks ago Customer Success Manager: Consumer Packaged Goods (CPG)QC Supervisor, Microbiology (2nd Shift, 1pm-9:30pm)Prepared Meals and Rotisserie Chicken AssociateFreezer, Cooler and Deli Stocker AssociateMedical Assistant - Pediatrics - 4.5 days/weekMedical Assistant - 4.5 days/week - Internal Medicine We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr