Manager, Technical Operations
Job Description
Title: Manager, Technical Operations
Company Name: Anshin International Company Limited
Vacancy: Not specific
Job Location: Dhaka
Employment Status: Full-time
Educational Requirements:
∎ Master of Pharmacy (M.Pharm), Master of Science (MSc) in Chemistry, Applied Chemistry
∎
Experience Requirements:
∎ At least 8 year(s)
∎ The applicants should have experience in the following area(s):
Production, Quality Assurance/ Quality Control, R & D
∎ The applicants should have experience in the following business area(s):
Pharmaceuticals, Toiletries
Job Responsibilities:
∎ Follow systems and procedures outlined in the company manuals. Ensure Company policies & procedures are followed.
∎ Comply all systems with GMP, QMS, safety requirements & other updated guidelines.
∎ Manage and monitor the implementation of GMP, QMS throughout the production, QC, QA & storage facilities.
∎ Ensure that the manufacture of medicinal & other products by the company is carried out in accordance with the Marketing Authorizations held for the product and in compliance with regulatory guidelines.
∎ Carry out regular internal audits & self-inspection programme, Record observations and adopt corrective actions.
∎ Handling of non-conformities, OOS (Out of specification), OOT (Out of Trend), customer complaints and recalls including investigation, corrective actions and follow up actions.
∎ Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including deviation, stability studies, product recalls, corrective & preventive actions (CAPA), and re-validations.
∎ Strictly follow the guidelines for approval of batch records, before releasing a batch.
∎ Maintain and develop the systems and procedures according to updated global Quality Systems to ensure compliance with regulatory requirements.
∎ Ensure effective and appropriate delegation of tasks and activities to the appropriate personnel.
∎ Supports the Technical Operations Department / Warehouse in delivering effective GMP, Quality training, training evaluation & training records.
∎
Additional Requirements:
∎ Thorough knowledge about IQ, OQ, PQ, product validation, process validation, method validation, cleaning validation & other related processes.
∎ Thorough knowledge about stability studies & its relative updated guidelines.
∎ Strong communication skill.
∎ Analytical ability and problem-solving attitude.
∎ Good Leadership skill.
Salary: Negotiable
Application Deadline: 17 Sep 2020
Company Information:
∎ 19 Aug 2020
∎ Anshin International Company Limited
Category: Production/Operation
