Senior Officer, Quality Assurance (Compliance)
Job Description
Title: Senior Officer, Quality Assurance (Compliance)
Company Name: Silva Pharmaceuticals Limited
Vacancy: 1
Job Location: Noakhali
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ Skills Required: BMR, Compliance, Documentation, Excellent communication skill, Pharmaceuticals, QUALITY ASSURANCE, Quality Management
Experience Requirements:
∎ At least 3 year(s)
∎ The applicants should have experience in the following area(s):
Pharmaceuticals, QUALITY ASSURANCE, Quality Controller/ Assurance
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals
Job Responsibilities:
∎ To oversee the activities of IPC section & report to Head of QA.
∎ To be Responsible for reviewing of BMR and BPR before batch release and also archive with proper traceability
∎ To be responsible for distribution, controlling and archiving of different GMP documents like BMR, BPR, SOP, STP, QMS documents and all sorts of documents of Plant.
∎ Checking of the new/ revised BMR, BPR, SOPs, others GMP documents before approval.
∎ To prepare & review APQR & Retrospective Process validation as pre the requirements.
∎ To be Responsible for preparation & reviewing of SOP (Standard Operating Procedure), SMF (Site Master File), Master List of Controlled Documents and other related GMP documents preparation & reviewing as per the instruction of Head of QA.
∎ To support validation related activities for the design, commissioning, qualification & continued validation of all equipment, facility & utility.
∎ Handle the QMS function like Change Control, Deviation, non-conformities, out of specification, Market Complaint, Product Recall & Risk Management.
∎ Internal and external audit facing and taking measures as suggested corrective and preventive actions.
∎ Monitoring of process validation & Cleaning validation activities
∎ Product manufacturing stage approval in absence of Head of QA.
∎ Conduct GMP related training to respective personnel as per training calendar.
∎ Preservation, record keeping & overall management of Retention Sample.
∎ Must have profound knowledge of WHO, TGA, UKMHRA, USFDA Regulations & Certifications.
∎ Arrangement of monthly meeting and preparation of minutes monthly & QA activities report and submitted to Head of QA.
Additional Requirements:
∎ Age 28 to 40 years
∎ Knowledge, Skills & Abilities: Excellent knowledge of GMPs, GLPs, GDP, ICH, CFR, DGDA Audit requirements, latest regulatory trends and global regulation as appropriate.
∎ Strong verbal and written communication skills.
∎ Excellent interpersonal, Strong analytical, problem-solving and leadership skills.
∎ Proficient with Microsoft Office Suite or related software.
Salary: Negotiable
Compensation & Other Benefits:
∎ T/A, Tour allowance, Medical allowance, Provident fund, Gratuity, Insurance
∎ Lunch Facilities: Full Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ Other Benefits: As per the Company rules
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 26 Jan 2023
Company Information:
∎ 27 Dec 2022
∎ 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
: 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
Source: bdjobs.com
Deadline Expired on 26th Jan 2023
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