Quality Compliance Specialist

Glenmark Pharmaceuticals Inc.•Monroe, NC

46d

About The Position

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.

Requirements

Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent
Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.
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.

Responsibilities

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