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Post Name: Deputy/ Quality Assurance Manager
Published on: 10 Jan, 2022
Application Deadline: 9 Feb 2022
- 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.
- 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
- 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):
- 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.
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
Jobs Source: online
Send your CV to email@example.com
Silva Pharmaceuticals Limited
How to apply on Silva Pharmaceuticals Limited
- At the very First, all you have to go to the Jiban Bima official website.
- JBC Job Apply Online
- Then you have to fill up the online form there
- You have to write down your father/mother/husband name, full address,
- Email ID, mobile number, district, Thana, union, word name,
- And respective community clinic name.
- After filling up the form, you have to submit it online.
- Then you will be provided the application ID and password.
- Finally, you have to download it and save it to get admit card.
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