Title: Sr. Executive / Assistant Manager, Validation (Pharma)
Company Name: DBL Pharmaceuticals Ltd. (A Concern of DBL Group)
Vacancy: Not specific
Job Location: Gazipur
Employment Status: Full-time
Educational Requirements:
∎ Masters in Sciences (i.e. Biology, Chemistry, Biochemistry, Pharmacy or Engineering) from any recognized university.
Experience Requirements:
∎ 6 to 9 year(s)
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
Job Responsibilities:
∎ Develop, establish, plans and implement validation activities as per validation master plan.
∎ Ensure site is at validation state and recommend validation strategies, priorities and resources.
∎ Prepare and maintain validation life cycle approach for site.
∎ Knowledge in depth on Quality Assurance processes, programs and strategies in line with the current regulatory requirements and company policies/procedures to support a quality systems approach.
∎ Develop, establish design for IQ/OQ/PQ and oversee the execution/implementation of the cleaning validation, equipment qualification, process validation, environmental validation programs.
∎ Develop and implement all necessary Standard Operating Procedures for validation of plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ) and re qualification of critical systems, utilities and production processes.
∎ Approve Validation Protocols and write validation final reports that present, summarize and offer conclusions on the validity of the process based on the results of the analysis.
∎ Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities and work with Regulatory Affairs Department to provide validation support for regulatory submissions.
∎ Implement requirements of regulatory guidelines (Such as WHO, UKMHRA, USFDA, PIC/S, ICH and local) and update compliance of the requirements.
∎ Detail knowledge and experience on Risk management.
∎ Lead the validation team and trained the team for validation activities. Also monitoring and provide support the execution of the protocols through training, facilitating and problem solving activities.
∎ Coordinate and interacts with multiple cross-functional groups within the company to drive validation activities in line with regulatory requirements and quality compliance. These functions include; facility and engineering, research and development, manufacturing/packaging, material management/warehousing, analytical laboratory, quality control, information technology and quality.
∎ Capable to review of analyze analytical and physical data generated from validation activities considering statistics methods.
∎ Ensure critical deadlines are met for achieving validation.
∎ Ensure data integrity.
Additional Requirements:
∎ Demonstrate thorough knowledge in process, cleaning, equipment and other validation/qualification systems;
∎ Strong Knowledge of GMPs guidelines/regulations/ (WHO, UKMHRA, 21 CFR 210/211, ICH Q7);
∎ Knowledge and experience on Statistical Process Control and Quality Management Systems;
∎ Proficient in Microsoft Word, Excel, Power Point and knowledge of other QMS software is a plus;
∎ Ability to inspire, lead, and develop people in a multi-cultural environment, establishing an atmosphere of mutual respect;
∎ Demonstrating proficiency in negotiating skills, conflict resolution and trust, adapting and working in a rapidly changing environment;
∎ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Compensation & Other Benefits:
∎ We offer excellent work environment, attractive compensation package and performance based career progression as per company policy.
Application Deadline: January 25, 2020
Company Information:
∎ DBL Pharmaceuticals Ltd. (A Concern of DBL Group)
∎ Address : Capita South Avenue Tower, 6th Floor
House No # 50, Road No # 03, Gulshan Avenue
Gulshan 1, Dhaka - 1212, Bangladesh
∎ Web : dblgroup.taleo.net/careersection/ex/jobsearch.ftl
Category: Medical/Pharma
Source: bdjobs.com