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GMP Compliance Manager - Midlothian, TX

GMP Compliance Manager
Location: Midlothian, TX
Reports to: Plant Manager
Position: Salaried
SCOPE OF POSITION
Manage and oversee the plant's responsibilities for compliance of production activities in accordance with Good Manufacturing Practices (GMP) and Q7 guidelines with the focus on personnel qualifications, internal audits, process validation, equipment qualification, change control (MOCs) and deviation investigations.
RESPONSIBILITIES
Manage the Compliance of all Production Activities including:
Prepare, review, approve and distribute production Standard Operating Procedures (SOPs).
Ensure that all production deviations are reported and evaluated.
Lead critical deviation investigations and document conclusions.
Lead the validation process making sure protocols and reports are reviewed and approved.
Lead the MOC process for proposed changes in product, process or equipment.
Lead the qualification process for new and modified facilities and equipment.
Manage the personnel qualification process through the designated trainers in KCl (Potassium Chloride) Blending, Repack, Caustic, Maintenance and Shipping to ensure that it is completed in a timely basis meeting regulatory requirements.
Plan and execute Internal Audits based on Q7 on a monthly basis.
REQUIREMENTS
Demonstrated knowledge, skills, and experience in GMP compliance methods, practices, tools, procedures applicable to a API manufacturing plant
Minimum 5 years' experience in GMP compliance in an API manufacturing plant ( over 5 years preferred).
Relevant Bachelor Degree required, with preference to Engineering and Chemistry degrees.
Proficient in Q7 principles, rules and guidelines with extensive practical experience in applying the rules to the specific manufacturing production process.
Excellent communication (written and verbal) and interpersonal skills.
Company Overview
People First!
By joining our team, you will have the chance to be part of a vibrant and growing company. We offer an exciting work atmosphere and opportunities for professional development. At Chemtrade, we take pride in rewarding our employees for their commitment, performance and hard work by offering a variety of programs and services. We offer a comprehensive and very competitive health and wellness program, including medical, dental, paid vacation and a fitness activity subsidy. Our unique culture enables employees to thrive in a supportive and engaging workplace. Employee engagement is not just something we talk about at Chemtrade, but fulfilled through exciting programs like Employee Recognition and Rewards (CHEers!), and Chemtrade University.
Our friendly work environment fosters positive interaction amongst employees within and throughout different departments and locations. We treat our employees with fairness and equity. We value diversity, recognize the benefits of an inclusive work environment and pride ourselves on our commitment to the Health and Safety of our employees and the communities we work in through Responsible Care?.
Chemtrade is one of the world's largest suppliers of sulphuric acid, liquid sulphur dioxide (SO2) and sodium hydrosulphite (SHS), and a leading processor of spent sulphuric acid. Chemtrade is also a leading regional supplier of sulphur and sodium chlorate, one of only two North American producers of phosphorous pentasulphide and also produces zinc oxide and water treatment chemicals. Chemtrade obtains these products from its own production facilities and through long-term marketing services agreements and distributes them to customers around the world. In January 2014, Chemtrade acquired General Chemical, a leader in water chemicals with nearly 50 North American production facilities. Chemtrade manufactures a broad line of organic and inorganic chemicals for a wide variety of industries and applications. Our products include aluminum sulfate, aluminum chlorohydrate, and ferric sulfate for water treatment applications. We stand behind our products with solid technical support. We are one of the leading producers across every business we service.
Chemtrade is an Equal Opportunity Employer
Chemtrade is committed to fair and accessible employment practices and will, where possible, provide accommodations for persons with disabilities.
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