PL Developments
Sr. Validation Manager
PL Developments, Lynwood, California, United States, 90262
JOB QUALIFICATIONS:
Bachelor’s degree in Engineering, Science or Quality preferred.10+ years of experience in validation and quality, focusing on the liquids pharmaceutical industry.Previous management/supervisory experience in validation or quality assurance.Knowledge of OSHA.Knowledge of FDA Guidance Process Validation: General Principles and Practices published January 2011.Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210, 211, 21 CFR 114 (acidified foods) and Part 11 Compliance.Working knowledge of ICH Q9 entitled “Quality Risk Management” published in June 2006 and ICH Q10 entitled “Pharmaceutical Quality Systems” published in April 2009.Proven ability to lead and manage validation teams, including mentoring, performance evaluation, and career development.Proficient with validation software and methods related to risk-based analysis, statistical process control, and process analytics.Ability to develop and implement validation strategies aligned with company goals and regulatory requirements.Ability to work with a high level of precision and attention to detail in a fast-paced environment while supporting multiple and changing priorities in validation.Expert level of Microsoft Office skills.Experience in Oracle systems such as Agile PQM.Strong interpersonal, written, and verbal communication skills for reporting, presentations, and interactions with regulatory agencies and other departments.Proven track record with continuous improvement initiatives and successful CAPA implementation.Strong analytical and problem-solving skills related to complex validation investigations.Extensive knowledge of the various state and federal cGMP and pharmaceutical validation laws and legislations that are enforced from time to time.POSITION RESPONSIBILITIES:
Under minimal supervision, manages and executes activities related to equipment, facilities, utility qualification, process, and cleaning validation.Generates, executes, and reviews validation and qualification protocols per related Standard Operating Procedures (SOP's), Risk Assessments and assures that acceptance criteria related to validation and qualification protocols areRequalification of existing equipment/processes as part of the lifecycle management of the product.Supports the development of best and proven validation practices in the validation department utilizing current industry guidelines and practices.Investigate exceptions and protocol deviations to determine the impact on the validation.Participates in cGMP audits as a validation subject matter expert.Provides advice and counsel to the site Leadership Teams and Director, Corporate Validation on validation compliance issues and risks.Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, participating in professional societies, etc.Schedules, plans, manages and executes studies for cleaning validation.Schedules, plans, manages and executes process validation studies and authoring related plans, protocols, and summary reports.Reviews and approves validation project documentation.Coordinates and interfaces with the R&D, operations, quality, and engineering groups to ensure successful project execution “right the first time.”Leads and coordinates cross-functional teams for project validation.Prioritizes, manages, and executes multiple projects utilizing project management methodologies.Oversees external validation resources that could be useful and evaluates that external documentation complies with PLD validation policy and procedures.Periodic travel to support validation activities at PLD sites.
Salary Range: $120-$130k DOE
HP#1
Bachelor’s degree in Engineering, Science or Quality preferred.10+ years of experience in validation and quality, focusing on the liquids pharmaceutical industry.Previous management/supervisory experience in validation or quality assurance.Knowledge of OSHA.Knowledge of FDA Guidance Process Validation: General Principles and Practices published January 2011.Knowledge of FDA/cGMP guidelines, 21 CFR Parts 111, 210, 211, 21 CFR 114 (acidified foods) and Part 11 Compliance.Working knowledge of ICH Q9 entitled “Quality Risk Management” published in June 2006 and ICH Q10 entitled “Pharmaceutical Quality Systems” published in April 2009.Proven ability to lead and manage validation teams, including mentoring, performance evaluation, and career development.Proficient with validation software and methods related to risk-based analysis, statistical process control, and process analytics.Ability to develop and implement validation strategies aligned with company goals and regulatory requirements.Ability to work with a high level of precision and attention to detail in a fast-paced environment while supporting multiple and changing priorities in validation.Expert level of Microsoft Office skills.Experience in Oracle systems such as Agile PQM.Strong interpersonal, written, and verbal communication skills for reporting, presentations, and interactions with regulatory agencies and other departments.Proven track record with continuous improvement initiatives and successful CAPA implementation.Strong analytical and problem-solving skills related to complex validation investigations.Extensive knowledge of the various state and federal cGMP and pharmaceutical validation laws and legislations that are enforced from time to time.POSITION RESPONSIBILITIES:
Under minimal supervision, manages and executes activities related to equipment, facilities, utility qualification, process, and cleaning validation.Generates, executes, and reviews validation and qualification protocols per related Standard Operating Procedures (SOP's), Risk Assessments and assures that acceptance criteria related to validation and qualification protocols areRequalification of existing equipment/processes as part of the lifecycle management of the product.Supports the development of best and proven validation practices in the validation department utilizing current industry guidelines and practices.Investigate exceptions and protocol deviations to determine the impact on the validation.Participates in cGMP audits as a validation subject matter expert.Provides advice and counsel to the site Leadership Teams and Director, Corporate Validation on validation compliance issues and risks.Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, participating in professional societies, etc.Schedules, plans, manages and executes studies for cleaning validation.Schedules, plans, manages and executes process validation studies and authoring related plans, protocols, and summary reports.Reviews and approves validation project documentation.Coordinates and interfaces with the R&D, operations, quality, and engineering groups to ensure successful project execution “right the first time.”Leads and coordinates cross-functional teams for project validation.Prioritizes, manages, and executes multiple projects utilizing project management methodologies.Oversees external validation resources that could be useful and evaluates that external documentation complies with PLD validation policy and procedures.Periodic travel to support validation activities at PLD sites.
Salary Range: $120-$130k DOE
HP#1