Deputy/ Quality Assurance Manager

Job Description

Title: Deputy/ Quality Assurance Manager

Company Name: Silva Pharmaceuticals Limited

Vacancy: 1

Job Location: Noakhali

Employment Status: Full-time

Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ M.Pharm from renowned University having the A-Grade Registration of Bangladesh Pharmacy Council (BPC)
∎ Skills Required: CAPA, cGMP, Compliance, GMP, good communication skill, MS Office, QUALITY ASSURANCE

Experience Requirements:
∎ At least 8 year(s)
∎ The applicants should have experience in the following area(s): CAPA, cGMP, good communication skill, MS Office, Pharmaceuticals, QMS, QUALITY ASSURANCE, Quality compliance, Quality Management
∎ The applicants should have experience in the following business area(s): Pharmaceuticals

Job Responsibilities:
∎ To manage, co-ordinate and direct all the activities of Quality Assurance department
∎ To lead the Quality Assurance team to assure Quality of Products manufactured at plant.
∎ To lead and manage all aspects of Operational Quality, Validation, Regulatory and Technical Support and Quality Assurance services.
∎ Promote Quality compliance and Quality Management System (QMS).
∎ Take overall responsibility of Product release to market Quality Compliance, Quality Council, Technology Transfer.
∎ Take responsibility for Audit & Inspection of manufacturing & supply units and to attend regulatory audits & Inspections by Internal and external bodies and lead the compliance.
∎ Lead a team of Qualified Persons (QP) ensuring training & development of quality professionals ensuring a robust talent development and succession plan.
∎ Ensure that Quality Risks are proactively managed.
∎ Create a healthy & safe environment to work and ensure that all the EHS standards are understood and applied.
∎ Maintain liaison with the government & non government's agencies.
∎ Lead New Technology Transfer products to be introduced to fulfill commercial ambitions.
∎ Handle QMS documents like product complaint, deviation, change control, reprocess, repacking etc.
∎ Manage proper distribution and implementation of updated SOPs and other documents.
∎ Implement the retention sample management system.
∎ Review the batch documents for batch release.
∎ 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.
∎ 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 establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan).
∎ 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.
∎ 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.
∎ Schedule and conduct Management Review Meeting as required by ISO 9001 standard.
∎ Additional duties as assigned.

Additional Requirements:
∎ Age at least 40 years
∎ 8 to 12 years practical work experience in any reputed Pharmaceuticals in relevant field
∎ 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 and well conversant in MS Office.
∎ Good interpersonal and communication skills.
∎ Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills.
∎ Strong personal & professional ethical values are essential for the position.
∎ Capable to work in a team and in shifting environment.

Salary: Negotiable

Compensation & Other Benefits:
∎ Mobile bill, Tour allowance, Medical allowance, Provident fund, Gratuity
∎ Lunch Facilities: Full Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ Career Growth Opportunity, Dormitory, Cell Phone Allowance, Lunch Facilities, Festival Bonus, Provident Fund, Insurance, Gratuity & other admissible benefits as per company policy

Job Source: Online Job Posting.

Application Deadline: 9 Feb 2022

Company Information:
∎ 10 Jan 2022
∎ Silva Pharmaceuticals Limited
∎ Address : House # 65, Road # 8/A (New), Dhanmondi, Dhaka-1209, Bangladesh
∎ Web :
∎ Business : Medicine Manufacturing, Marketing & Distribution Operation

Category: Production/Operation

: 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 Email

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