Piramal Pharma Ltd
Join to apply for the Sr. Manager AQC role at Piramal Pharma Ltd
Location: Lexington, KY | Salary: $50,000.00-$60,000.00 | 2 days ago Be among the first 25 applicants | Posted: 3 days ago
Job Overview Reporting to the Director of Quality, the Sr. Manager, Analytical Quality Control ("AQC") has responsibility for the Analytical Quality Control AQC laboratories. The position will provide strategic direction and leadership to improve quality, efficiency and capability.
Job Description Business: Pharma Solutions
Department: Analytical Quality Control
Location: Lexington
Reporting Structure This position reports to the Director of Quality
Key Responsibilities
Direct oversight of activities performed within Quality Control Laboratories
Monitor revenue goals ensuring that Laboratories meet or exceed expectations
Develop and manage department budgets
Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
Oversee all quality investigations within the departments (deviations, CAPA and LIR)
Ensure Lab Sustain Permanent Inspection Readiness (PIR)
Ensure suitable laboratory safety procedures are in place
Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
Ensure that department technical expertise and capabilities are constantly evolving and current with industry.
Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators
Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs.
Encourage an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
Lead and mentor individual group members
Assign department resources so that company goals/timelines are achieved
Qualifications
B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
Strong/demonstrated knowledge of cGMP regulations
Possess excellent technical writing and oral communication skills
Six Sigma Green Belt, Benchmarking and Project Management experience preferred
About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal Employment Opportunity Piramal Group is proud to be an Equal Employment Opportunity and affirmative action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Seniority Level
Director
Employment Type
Full-time
Job Function
Other
Industries: Pharmaceutical Manufacturing
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Location: Lexington, KY | Salary: $50,000.00-$60,000.00 | 2 days ago Be among the first 25 applicants | Posted: 3 days ago
Job Overview Reporting to the Director of Quality, the Sr. Manager, Analytical Quality Control ("AQC") has responsibility for the Analytical Quality Control AQC laboratories. The position will provide strategic direction and leadership to improve quality, efficiency and capability.
Job Description Business: Pharma Solutions
Department: Analytical Quality Control
Location: Lexington
Reporting Structure This position reports to the Director of Quality
Key Responsibilities
Direct oversight of activities performed within Quality Control Laboratories
Monitor revenue goals ensuring that Laboratories meet or exceed expectations
Develop and manage department budgets
Regularly monitor applicable internet and written information published by US FDA, pharmaceutical manufacturing and laboratory technology organizations for the purpose of review/incorporation of latest requirements and guidelines into routine PPS laboratory operations
Establish short and long-range plans for the timely and efficient execution of the testing activities within scope of the business priorities and applicable regulatory requirements (FDA, OSHA, etc.)
Apply necessary oversight to the stability study program and ensure current regulatory guidelines are followed
Oversee laboratory instrumentation activities including procurement, qualification, preventative maintenance, and calibration
Establish, implement, and manage Laboratory Programs and/or Policies, SOPs, and good record keeping practices that are compliant with current regulatory requirements
Oversee all quality investigations within the departments (deviations, CAPA and LIR)
Ensure Lab Sustain Permanent Inspection Readiness (PIR)
Ensure suitable laboratory safety procedures are in place
Ensure that there is a department training program in place so that department staff are continuously developing and are current with industry practice
Ensure that department technical expertise and capabilities are constantly evolving and current with industry.
Provides information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries
Analyze and trend sample results and perform statistical studies and evaluations of key performance indicators
Develop mechanisms and structures to allow for adjustment in the laboratory testing schedules to meet changing priorities due to business needs.
Encourage an environment where department members seek opportunities to improve current practices in terms of quality, efficiency and safety
Lead and mentor individual group members
Assign department resources so that company goals/timelines are achieved
Qualifications
B.A. or B.S in scientific related field, Biology, Life Science, Chemistry, or related scientific discipline preferred
Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience
Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus
Strong/demonstrated knowledge of cGMP regulations
Possess excellent technical writing and oral communication skills
Six Sigma Green Belt, Benchmarking and Project Management experience preferred
About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal Employment Opportunity Piramal Group is proud to be an Equal Employment Opportunity and affirmative action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Seniority Level
Director
Employment Type
Full-time
Job Function
Other
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr