QA Product Manager
Catalent Pharma Solutions
Metropolitana de Santiago, Metropolitana de Santiago, CL
hace 10 horas
source : WHATJOBS

I. Department Overview :

The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent’s St.

Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.

II. Basic Function :

The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St.

Petersburg’s customers and internal organizations. This position serves as a representative for their clients within the Catalent St.

  • Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to : a) change controls and associated Master documents, including but not limited to MERs and material Specifications;
  • Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ / OQ / PQ documents regarding equipment, utilities, and computer systems;
  • b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents;
  • d) all Preventive Maintenance and Calibration work order requirements for critical systems.

    III. Specific Activities, and Responsibilities :

    CUSTOMER FOCUS

    Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.

    Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.

    Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.

    Generate quality metrics, trackers, and reports for management and clients to characterize the health of the client relationship and state of quality systems

    TECHNICAL

    Provide QA Technical recommendations based on trend analysis to eliminate future problems.

    Participates in Product Development / Validation / Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.

    Reviews and approves technical documents, such as, but not limited to :

  • Technical Services Protocols and Reports;
  • Process Validation Protocols and Reports

    Cleaning Validation Protocols and Reports

  • IQ / OQ / PQ Protocols and Reports;
  • MERs and material Specifications;
  • Product specifications;
  • Test methods;
  • Master Batch Records; and

    Master Shipper Labels.

    Change Control, as it pertains to the above validated / qualified systems and controlled documents

    Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA / MCA regulatory guidelines).

    Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.

    COMPLIANCE

    Provide support to internal, client, and regulatory audits.

    Engage in monitoring quality systems to maintain awareness and audit / inspection readiness at all times.

    Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.

    IV. Knowledge Requirements :

    Education or Equivalent :

    Bachelors Degree in Science (Chemistry, Microbiology or Biology preferred) required

    A minimum of five to ten years related experience and / or training and / or equivalent combination of education and experience in the QA pharmaceutical industries.

    Prior experience working with validation, manufacturing or product development preferred.

    Proven ability to multi-task and demonstrate diplomatic skills.

    Must possess excellent English verbal and written communication skills.

    Intermediate to proficient skills in Microsoft Office applications

    Knowledge / Skills Requirements :

    Prior quality assurance experience is required.

    Working knowledge of cGMPs and / or OSHA regulations required.

    Certified Quality Engineer is a plus.

    Excellent oral and written communication skills a must.

    Proficient in Microsoft Word, Excel, Access and Power Point.

    Ability to speak effectively and present before groups within the organization.

    Ability to review and evaluate technical documents and determine impact to processes and systems in place.

    Ability to solve problems with minimal guidance.

    Ability to review and write protocols, reports, and procedure manuals.

    Ability to effectively present information and respond to questions from peers, management, suppliers and customers.

    Motivated, self-started, team player

    Physical / Mental Requirements :

  • Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds;
  • no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment.

    Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

    Work Environment :

    Individual’s primary workstation is in the office area, where the noise level is low.

    To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    This job description reflects the general duties of the job, but is not a detailed description of all duties which may be inherent to this position.

    Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

    Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

    Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

    Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

    Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety.

    The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

    personal initiative. dynamic pace. meaningful work.

    Visit Catalent Careers to explore career opportunities.

    Catalent is an Equal Opportunity Employer, including disability and veterans.

    If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations catalent.

    com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.

    S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    Notice to Agency and Search Firm Representatives : Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and / or search firms for this job posting.

    Resumes submitted to any Catalent employee by a third party agency and / or search firm without a valid written & signed search agreement, will become the sole property of Catalent.

    No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

    Important Security Notice to U.S. Job Seekers :

    Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media.

    If you receive any such request, DO NOT respond it is a fraudulent request. Please forward such requests to spam catalent.

    com for us to investigate with local authorities.

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