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    Senior Manager; QA Compliance - Hauppauge, United States - Contract Pharmacal Corp

    Contract Pharmacal Corp
    Contract Pharmacal Corp Hauppauge, United States

    4 weeks ago

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    Paid Work
    Description

    Senior Manager; QA Compliance (Audits)

    Hauppauge, NY )
    • Quality Assurance

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    Description

    Position Summary:

    The Sr. Manager of Quality Assurance Compliance – Audits has primary responsibility for all activities related to cGMP audits including hosting regulatory, customer, certification audits and directing/conducting all 3rd party and internal audits. In addition, the position is responsible for managing the Document Control team and facility compliance to support audit functions.

    Responsibilities:Responsibilities include, but are not limited to:

    Audit Program:

    · Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards.

    · Oversee the Foreign Supplier Verification Program

    · Establish audit teams with appropriate skill sets

    · Report audit findings

    · Evaluate corrective action plans and monitor completion

    · Ensure audit schedule adherence

    · Issue audit closure letters

    · Schedule, host, and respond to regulatory, customer, and certification audits

    · Coordinate audit documentation and personnel

    Document Control:

    · Approve SOPs and other cGMP documentation as needed.

    · Master and Production Batch Record retention

    · Release bulk and finished product to market

    Facilities:

    · Pest Control Program

    · Environmental Monitoring Program

    · Change Control Approval

    · Equipment IQ/OQ

    · Metrology

    · Food Defense Plan and subject matter expert.

    · Monitor facility metrics

    Supplier/Contractor Qualification:

    · Conduct Audits

    · Maintain Qualified Supplier list

    · Prepare and/or approve Annual Product reviews (APRs)

    · Prepare and/or approve Customer, Contractor and Supplier Quality Agreements

    Requirements

    Education and Experience:

    · Bachelor's degree in science, compliance, or related required

    · Master's degree preferred

    · 5+ years of GMP managerial experience within pharmaceutical quality assurance and compliance.

    · Minimum 2 years conducting and hosting GMP audits of pharmaceutical and/or supplement manufacturers.

    · Preferred Certifications:

    . Foreign Supplier Verification Program

    .Preventative Controls for Human Food

    .Preventing Intentional Adulteration of Human Food

    .ASQ Certified Quality Auditor (CQA)

    Skills, Abilities and Knowledge:

    · US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing

    · Pharmaceutical Quality Systems

    · ICH, USP, and EP Guidance

    · Analytical principles and manufacturing processes

    · Validation study designs (e.g., method, cleaning, process)

    · Data analysis

    · Effective written and oral communication skills to all employee levels

    · Knowledge of computer program validation principles

    · Excellent technical writing skills and attention to detail

    · Experience in auditing compliance (e.g. EU, FDA, GMPs)

    · Ability to manage multiple tasks and meet deadlines

    · Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook

    · Required training in SOP, cGMP, and General Safety procedures

    Physical Demands:

    · Required to use hands to operate computer controls.

    · Specific vision abilities required include close vision, ability to focus.

    Work Environment:

    · Required to be present in the office to collaborate with directors, peers and other departments daily.

    · Responsible for adherence to safety policies.

    · Flexible schedule to meet business requirements

    Supervisory Responsibilities:

    · Responsible for managing non-union employees

    Salary Range:

    $90,000 - $120,000 per year


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