Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit.
Job Title: Compliance Coordinator
Job Location: Bristol, Tennessee
· Compiles, reviews, closes, tracks, and/or monitors site Corrective and Preventive Actions (CAPA).
· Interfaces with vendors and appropriate above-site groups as required to maintain a current list of approved material suppliers for the site. Evaluates above-site audit reports and communications and ensures prompt communication of supplier issues to management and departments, as appropriate.
- Performs documented physical review and evaluation of Processing batch records (including final evaluation for batch release) to ensure completeness and accuracy. Provides notification to management of situations requiring technical action. Approves batch progression/release or executes rejection as appropriate.
- Participates in site audits as auditee and/or auditor and assists with corporate and regulatory audits
- Authors, reviews, coordinates, and/or completes tasks of site change controls.
- Compiles annual reports
- Performs cGMP training responsibilities per CFR and site requirements.
- Participates (contributes or leads) customer complaint investigations.
- Participates (contributes or leads) in plant investigations in accordance with cGMP Rule 21 CFR 211-192 as required to support key responsibilities.
- Reviews/revises plant SOP’s (Standard Operating Procedures) as applicable to the above responsibilities.
- Miscellaneous related activities as assigned.
· MUST NOT BE ALLERGIC TO PENICILLIN.
· Strong knowledge of FDA regulations, cGMPs and labelling requirements.
· Knowledge of CFR and pharmacopoeial requirements.
· Knowledge of audit procedures related to the FDA and other regulatory agencies.
· Management skills.
· Bachelor’s degree in Chemistry, Pharmacy, BioScience or equivalent combination of education and work experience.
· Minimum of 7 years of experience in Production, Quality Control or Quality Assurance in the pharmaceutical industry or equivalent experience.
· Analytical thinking and technical knowledge.
· Auditing skills and experience.
· Computer skills in standard corporate software and systems (e.g., SAP , LIMS, and typical office software).
· Strong verbal and written communication skills.
· Knowledge of cGMP and USP and validation concepts.
· Ability to make decisions and function independently.
· Prefer Master’s degree in related science.
· Prefer experience in production or R&D will be an added advantage.
· Prefer Quality-related certification.
· Prefer U.S. and international regulatory experience.
· Prefer good technical writing skills.
Dr. Reddy's Laboratories, Inc. - 17 months ago