Head of Quality Compliance
Job Description
Title: Head of Quality Compliance
Company Name: Delta Pharma Ltd.
Vacancy: Not specific
Job Location: Kishoreganj (Pakundia)
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm)
∎ Professional Certification: Candidates must be registered in Pharmacy Council of Bangladesh
Experience Requirements:
∎ At least 20 year(s)
Job Responsibilities:
∎ Assurance and enforcement of cGMP in production, quality control, warehouse, engineering facilities. On time Management of compliance activities like risk management, CAPA management, deviation, change control, market complaint, returned goods management, self Inspection, internal & external audit etc
∎ Preparation & implementation of SOP's, Protocol, SMF, VMP, DMF, CTD & eCTD, Quality Manual, APQR, QMS related documents and other quality documents.
∎ Ensuring calibration, process validation, analytical method validation, cleaning validation, vendor validation and qualification of machinery, equipments, HVAC systems, compressed air system, purified water system, steam system and effluent treatment system.
∎ Preparation of training module and conduct GMP training and others training for the relevant factory personnel.
∎ Preparation and update of specifications of raw materials, packaging materials and finished products.
∎ Ensuring physical, chemical & biological tests of raw materials, intermediates, bulk and finished products of all dosage forms, dispensing of raw materials, release & rejection of raw materials, packaging materials and finished products.
∎ To evaluate proper batch documentation system, reviewing data, assessing & solving the problems.
∎ Identification of the part of the process where in process control check are required and its implementation.
∎ Monitoring and control of the manufacturing environment and plant hygiene.
∎ Responsible for release the batch of product for marketing.
∎ Fulfillment of regulatory requirements of home and abroad.
∎ Assist the Executive Director (Plant) to develop quality standards, rules & regulations and accomplish the goals and strategic plans.
∎ Coordination with Quality assurance, Quality Control, Product Development, R&D, Production and Engineering Department for proper support in all quality related matter/activities.
∎ Conducting any type of inspection by ISO and others Regulatory bodies from home & abroad. Completing the inspection report according to inspected results.
Additional Requirements:
∎ Age 45 to 50 years
∎ Skills Required : cGMP, Compliance, Documentation, Drug Rules & Regulations, Formulation, Product Development, Presentation
∎ The applicants should have experience in the following area(s): cGMP, Formulation, Pharmaceuticals, Quality Controller/Assurance, Quality Management, Regulatory Affairs.
∎ The applicants should have experience in the following business area(s): Pharmaceuticals.
∎ Additional Requirements:
∎ Must have working knowledge on Product development and R&D section.
∎ Must have Administrative, Leadership & Managerial skills.
∎ Must have Strong analytical, strategic thinking, commendable presentation, decision making and problem-solving skills with the ability to work independently under the strictest deadline are required.
∎ Must have excellent communication in English (Written & Verbal) and Interpersonal skills.
∎ Must have Efficiency, flexible, high level of professionalism and ability to work under pressure.
∎ Must have Positive work ethics and result oriented for assigned responsibilities.
∎ Should be self-driven and hardworking.
∎ Must have sound knowledge in computer applications.
∎ Candidate must have to stay with family at Pakundia or Kishoreganj.
Compensation & Other Benefits:
∎ Mobile bill, Tour allowance, Provident fund, Insurance, Gratuity, Benevolent Fund.
∎ Lunch Facilities: Company Provided in-office time.
∎ Salary Review: Yearly.
∎ Festival Bonus: 2 (Yearly).
∎ Foreign Tour.
Application Deadline: 5 Oct 2020
Company Information:
∎ 22 Sep 2020
∎ Delta Pharma Ltd.
∎ Address : House-501,Road-34,New DOHS,Mohakhali,Dhaka-1206.
∎ Web : www.deltapharmabd.com
∎ Business : Pharmaceutical
Category: Medical/Pharma
