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Quality Compliance Specialist

Department: Quality

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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company.

POSITION SUMMARY:

Under the direction of the Senior Manager, Quality Compliance, the Quality Compliance Specialist is responsible for managing the investigation and resolution of Quality Systems notifications including, but not limited to: Complaints, Field Alerts and Recalls, Vendor and Contract Lab Qualifications, Internal and External Audits. This individual works closely with cross-functional teams at the site and abroad. This individual will routinely report on system and business process performance; proactively identifying, providing guidance and implementing process and system improvements to resolve complex issues in a timely manner. This position will also provide site representation for regulatory surveillance program.

JOB RESPONSIBILITIES:

Financial:

Provide support in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.

Operational Excellence:

+ Ensures that complaints are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements.

+ Coordinates the reviews of relevant records, (e.g. batch records, quality control data, quality investigations, etc.)

+ Tracks quality system metrics related to complaints and creates detailed trend analysis reports. Prepares formal reports for complaint closing.

+ Ensure that site is in compliant with CGMPs in respect to internal/external regulations and procedures.

+ Provide support in evaluation of implementation for Global Policies and Procedures

+ Evaluates and assists in the implementation of new changes for the site.

+ Supports implementation of projects that improve site Quality and/or efficiency.

+ Keep track of certified auditors for internal audit and external audit (vendor/CTL)

+ Keep records maintained for audit reports pertains to vendors and CTL at site along with schedule.

+ Participate in regulatory surveillance program and work with CFT members for necessary changes to prevent similar observations at the site.

+ Provide support in handling of Field Alerts and Product Recall as required for marketed products

+ Approves creation or modification of Materials and Vendors.

+ Creates or modifies Quality view data such as: shelf life and Quality Info Record (QIR) based on Vendors qualification status.

+ Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate or vendor audits and audit readiness related activities.

+ Support internal and external/regulatory audits / inspections when required.

Stakeholder:

+ Ensure site is in compliant with CGMPs and internal/external regulations and procedures.

+ Provide guidance and work with stakeholders from various departments to process complaints, internal and external audit CAPA and follow-up with external parties (Vendor/CTL) for audit closure.

+ Provide required support in Annual Product Review

Innovation:

+ Establish, revise, review and continuously improve procedures for applicable Quality Systems.

+ Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target.

Education:

Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent

Experience:

Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills :

Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.

Must be proactive, results-oriented with a strong attention to detail and strong time management skills.

Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment.

Ability to analyze details and perform structured decision-making on a daily basis.

Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English.

Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.

Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools.

Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.

Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.

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