PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.
SUMMARY :
We are seeking an experienced and highly skilled Quality Assurance Manager to lead and oversee all aspects of our quality assurance programs. This position is responsible for ensuring compliance with regulatory standards, maintaining robust quality systems, and driving continuous improvement initiatives across the organization. Work Schedule : Monday - Friday, minimum of 40-45 hours per week
JOB QUALIFICATIONS :
- BA / BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering, etc. or equivalent combination of education and experience.
- Must have 10 years minimum experience in pharmaceutical industry working with solid oral dosage forms.
- Must be an effective communicator and understand written procedures.
- Strong leadership skills.
- Very knowledgeable in cGMPs, FDA regulations, and FDA Guidance.
- Planning and organization; and ability to plan and manage multiple projects.
- Attention to detail.
- Excellent interpersonal and communication skills.
- High performance team and strong team player.
- Ability to work with all levels in the organization to maintain communication, action and promote cultural change to embed new ways of working.
- Able to work under pressure and meet deadlines.
- Computer literate.
POSITION RESPONSIBILITIES :
Oversees and maintains the quality systems.Participate in management meetings.Develop, supervise, and train QA employees.Assist with hosting FDA inspections and external GMP audits.Ensure company conformance to Good Manufacturing Practices requirements.Supervise the update and maintenance of master batch recordsSupervise the development of raw material and finish product specifications.Handle customer complaints.Analyze quality data to detect unsatisfactory trends conditions and weaknesses in the quality system.Develop, implement, and maintain standard operation procedures through the Change Control Notice System.Review and approve Process validation, equipment qualification activities.Review and approve investigations, deviations, and change control notices.Coordinate the implementation of the Internal Quality Systems Audit program.Prepares, Reviews and assists with all documentation for international registration purposes.Recommend corrective and preventive actions.Maintain and develop effective collaboration with other departments.Develop and / or support strategies for continuous quality improvement in systems and products.Reviews and Approves BR’s and COA’s for finished product final disposition.Review product developments, protocols and reports from quality perspective for adherence to applicable regulations.Assure appropriate CAPA are implemented and tracked as part of the deviations / investigations.Review and approve NCMR for proper final disposition.Oversees deviations / investigations to determine root cause and assure timely resolution.Assists with the QC product, material and component specifications as neededPHYSICAL REQUIREMENTS :
Adhere to all safety policies; includes wearing personal protective equipment when requiredLight physical activity performing non-strenuous daily activities of an administrative natureIncluding but not limited to : Sitting for greater than 75% of your time, standing and walking for up to 25% of your timeManual dexterity sufficient to reach / handle items and work with the fingersUse of hands to fingers for typing and other computer activity for up to 75% of your timeReaching with hands and arms, climb or balance, stoop, kneel, crouch, or crawl less than 25% of your timeAbility to lift, up to 50lbs, less than 25% of the time
BENEFITS :
PLD is a proud employer offering many corporate benefits, including :
Medical and Dental BenefitsVision401K with employer matchGroup Life InsuranceFlex Spending AccountsPaid Time Off and Paid HolidaysTuition AssistanceCorporate Discount ProgramOpportunities to Flourish Within the CompanyPL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.