Job Description

JOB PURPOSE :

Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials.

Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated.

KEY ACCOUNTABILITIES:

• Regular and predictable onsite attendance and punctuality.
• Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner.
• Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials.
• Coordinates communication of production status to next shift; attends daily update meetings as required.
• Manages personnel for in-process filling and inspection/packaging monitoring.
• Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required
• Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTRs, Commissioning Documents, FATs), engineering documents.
• Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
• Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials.
• Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
• Places lots on HOLD if Quality issues are detected and notifies senior management.
• Assists the QA management in developing on department budget.
• Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
• Manages attendance records for all direct reports.

QUALIFICATIONS:

• College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years experience, or Masters Degree in Microbiology, or biological science with 3-6 years experience
• Ph.D. in relevant field with 0-3 years experience
• Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial

EXPERIENCE:

• Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must

SKILLS:

• Must have history of strong documentation skills and attention to detail
• Familiarity with cGMPs and CFR for US and EU
• Excellent organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to lead a department, projects and meetings effectively
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
• General computer skills and ability to prepare presentations and address large groups
• Demonstrated attention to details and accuracy
• The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
• Mentoring abilities as well as effective communication, (written and oral) are required.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

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