The major job is to establish procedures and quality standard and to monitor these against agreed target of the organization. Independently manages review and approval of master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements. Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition. Leads, trains others and approves Quality investigations. Leads the review and approval of change control requests to ensure compliance with all applicable requirements. Lead QA representative, including compliance responsibility, on the internal Silva team. Leads and trains others in internal audit and vendor management programs. Prepares and presents quality metrics. Independently initiates and approves SOP updates and creation of new SOPs. Additionally, oversees review of SOPs and associated documentation to ensure biennial review requirements are met. Lead Quality representatives for regulatory inspections. Lead establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan). Ensure Quality processes at PCYC and across the supply chain comply with all applicable regulations and guidelines. If this position has direct reports: Provide technical guidance and timely performance feedback through routine 1:1 meetings. Provide technical development through OTJ training. Work with HR to ensure opportunities for professional development. Assist with developing individual goals and objectives. Ensure that all quality and regulatory requirements (as per cGMPs, ICH and ISO 9001 standard) is effective, implemented and continuously improving for all products and processes. Ensure that concerned personnel of the organization are trained in relation to Quality Management System Requirements Develop and maintain internal audit program and standing systems, which deal with nonconforming product (NCR), customer inquires (CI), corrective and preventive actions (CAPA), track and monitor these actions until closure. Acts as a quality liason with regulatory authorities and external auditors during inspections. Schedule and conduct Management Review Meeting as required by ISO 9001 standard. Prepare detailed summary reports, review data, analyze trends, and drive corrective actions for significant issues. Additional duties as assigned.
Master of Pharmacy (M.Pharm)
Age 30 to 40 years Must have the A-Grade Registration of Bangladesh Pharmacy Council (BPC) Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems. Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background. Detail oriented with demonstrated problem solving acumen. Ability to work effectively in a team environment with great organization skills. Ability to independently analyze and reconcile complex issues. Must be an individual with proven initiative and accountability Must be able to lead in a fast paced environment. Excellent verbal and written communication and interpersonal skills. Proficient with computers and typical office software (i.e., Microsoft Office products).
7 Years
Negotiable
T/A, Mobile bill, Tour allowance, Medical allowance, Provident fund, Gratuity. Lunch Facilities: Full Subsidize. Salary Review: Yearly. Festival Bonus: 2. Other Benefits: As per the Company rules
Only males are allowed to apply
Full Time
Noakhali
02-10-2020
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