Assistant Manager, Quality Assurance
Job Description
Title: Assistant Manager, Quality Assurance
Company Name: Silva Pharmaceuticals Limited
Vacancy: 1
Job Location: Noakhali
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ Skills Required: Compliance, Computer skill, Documentation, Excellent communication skill
Experience Requirements:
∎ At least 7 year(s)
∎ The applicants should have experience in the following area(s):
Quality Controller/ Assurance
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
Job Responsibilities:
∎ 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.
Additional Requirements:
∎ 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).
Salary: Negotiable
Compensation & Other Benefits:
∎ T/A, Mobile bill, Tour allowance, Medical allowance, Provident fund, Gratuity
∎ Lunch Facilities: Full Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ As per the Company rules
Application Deadline: August 31, 2019
Company Information:
∎ Silva Pharmaceuticals Limited
∎ Address : House # 65, Road # 8/A (New), Dhanmondi, Dhaka-1209, Bangladesh
∎ Web : www.silvapharma.com
∎ Business : Medicine Manufacturing, Marketing & Distribution Operation
Category: Medical/Pharma
Read Before Apply: Apply with an updated CV and recent passport size color photograph addressing Head of HR, Silva Pharmaceuticals Limited, House # 65, Road # 8/A (New), Dhanmondi, Dhaka-1209 mentioning the position applying for on top of the envelope or in the subject field of e-mail attachment.
Deadline Expired on 31st Aug 2019
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