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PuraCap
QA Manager (PR)

 

QA Manager (PR)

Location: Dorado, Puerto Rico

 

Position Summary

The QA Manager is responsible of overseeing the Quality Assurance functions while ensuring compliance with regulatory agencies. This position is responsible as a Site Subject Matter Expert (SME) to provide Shop floor quality perspective review and approval, of in-line/offline manufacturing batch records associated to all manufacturing and packaging process and to directly overlook manufacturing activities to assure that these are performed within the framework of corporate/governmental policies and regulations (cGMP’s). Also responsible for plant wide review and approval of Quality Events investigations associated to site operations and Master Documents such as qualification/ validation protocols/reports. Is responsible for the development, implementation and enforcement of Quality Assurance systems and programs to enable the company to consistently satisfy its current/future product quality assurance requirements. Manages the establishment and improvement of quality assurance activities within the manufacturing and packaging areas to ensure product quality.

KEY RESPONSIBILITIES:

  1. Accountable for the establishment of all objectives, strategies and action plans embodied in quality assurance services.  Responsible for all quality assurance programs, control, monitor and reduce the cost of quality while ensuring high quality standards are met.
  2. Through his/her direction, oversees shop floor manufacturing and packaging activities in order to provide SME quality guidance and/or approval to ensure full compliance with cGMP’s and other regulations.
  3. Ensures the proper reviews and approvals of the executed batch records pertaining to the preparation, formulation, granulation, compressing, coating and printing or any additional stage (e.g. inspection) of the final dosage form of all products manufactured in the site.
  4. Identifies improvements in the working area related to documentation design and flow to the process area.
  5. Evaluates quality incidents on the shop floor and provide guidance to operations areas to drive thorough investigations. Assures that Site Quality Events (QE) are completed within the time frame provided in site procedure. If time extension is required, assure timely submission of required documentation.
  6. Evaluates and approves investigations and CAPA’s for returned goods, damaged goods, process deviations and laboratory investigations.
  7. Reviews Quality Events Reports performed by operational areas to assure that Root Cause was identified, adequacy of correctives and preventives actions taken and proposed, report redaction and format is adequate, clear and in compliance with procedure.
  8. Reviews and approves completed CAPAs. Provides advice and service to all operating departments as to assure compliance with cGMP’s and other regulations. (This includes frequent feedback on performance regarding deviations, rejections, complaints, outstanding commitments, trends, etc.).
  9. Supports readiness exercises for regulatory inspections. Participates actively in Regulatory inspections and / or during internal company audits.
  10. Writes, reviews and implements departmental procedures to assure update with current practices or GMP trends. Reviews and provides Quality Approval to operational areas procedures and Manufacturing Master Documents assuring compliance with current practices and/or GMP trends.
  11. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials. Suggests improvements in the working area related to documentation design and flow to the process area.
  12. Escalates to management relevant situations that may impact product disposition and may cause product shortage in the market.
  13. Reviews and approves validation/qualification protocols and final reports, such as, but not limited to: Equipment Qualification, Process Validation, Computer Validation, Method Transfer & Validation, and Periodic Reviews. Provides quality perspective and approval for change controls.
  14. Responsible for the delivery of GMP and/or SOP’s training as required.
  15. Prepares department budget and control expenses within approved amounts.
  16. Carries out other duties as assigned that are deemed reasonable and within the broad scope of the position.

COMPETENCIES – To perform the job successfully, an individual should demonstrate the following competencies:

Conflict Management-Reads situations quickly & steps up to conflicts & settles disputes equitably.  Good at focused listening. Can find common ground & get cooperation with minimum noise.

Action Oriented-Enjoys working hard.  Is action oriented and full of energy for the things he/she sees as challenging. Not fearful of acting with a minimum of planning.  Seizes more opportunities than others.

Planning-Accurately scopes out length and difficulty of tasks and projects. Sets objectives and goals. Breaks down work into the process steps. Develops schedules and task/people assignments. Anticipates and adjusts for problems and roadblocks. Measures performance against goals.

Directing Others-Is good at establishing clear directions, distributes the workload appropriately, brings out the best in people.

Decision Making- Makes decisions in a timely manner, sometimes under tight deadlines and pressure.  Able to make a quick decision.

Problem Solving-Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all fruitful sources and looks beyond the obvious for answers. Can see hidden problems. Is excellent at honest analysis.

Business Acumen- Knows how businesses work.  Knowledgeable in current & possible future policies, practices, trends, developments in his/her business.

Dealing with Ambiguity- Can comfortably handle risk and uncertainty.  Can effectively cope with change and shift gears comfortably. Doesn’t have to finish things before moving on.  Can decide and act without having the total picture.

Quality and Compliance- Adheres to standard operating procedures, defined practices & regulations.  Attentive to detail & accuracy with optimal speed & volume.  Committed to excellence & continuous improvement.  Produces work that is right the first time, always with the customer in mind.

SUPERVISION – This position has supervisory responsibilities.

WORK CONDITIONS – Office environment. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Specific vision abilities required by this job include close vision and distance vision.

 

TRAINING AND EXPERIENCE:

  • Education: Bachelor’s Degree in Science (Microbiology, Chemistry, and General Sciences), Engineering or Pharmacy. Self-motivated, creative and team work oriented. Able to work under pressure and availability to work at any time needed. Available to work rotating shifts and extra hours. 
  • Training: In-depth knowledge of requirements of cGMP’s.
  • Previous experience: A minimum of five (5) years of experience in Pharmaceutical Manufacturing Industry with exposure to Quality and Manufacturing field. Exposure to a regulatory affairs environment.  Exposure to FDA audits as the front person in the process.
  • Certificates, Licenses or Registrations: Licenses are preferred.

 

SKILLS:

Incumbent must have a broad knowledge on Quality Systems such as Change Control, Investigations and CAPA’s. Must be fully bilingual in both English and Spanish, with strong, thorough, and concise written and verbal communications skills and above average computer literacy (MS-Office).  Broad knowledge of relevant governmental regulations, cGMPs and guidelines. Solid technical writing skills related to investigation reports. Ability to create / organize cGMP systems procedures based on regulatory / compliance requirements.  Incumbent must possess strong mathematical skills.  Excellent technical writing skills are required.

 

To learn more about PuraCap Pharmaceutical, visit http://puracap.com/

To apply for this position, email your resume and a cover letter to humanresources@PuraCap.com

Not only is PuraCap an internationally inclusive company, but we embrace and encourage diversity. PuraCap is proud to be an equal opportunity workplace and is an affirmative action employer.