Executive, Quality Assurance

Job Description

Title: Executive, Quality Assurance

Company Name: Opsonin Pharma Limited

Vacancy: --

Age: At most 30 years

Job Location: Barishal

Salary: --

Experience:

• 1 to 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Master of Pharmacy (M.Pharm)

• 1 to 2 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies
• Freshers are also encouraged to apply.

• Age At most 30 years

• 1-2 years of working experience in any Pharmaceutical Company is preferred.

• Proficient in word processor and spreadsheet

• Willing to work under pressure

• Good team player

• Excellent command over computer operation (MS-Office, Internet)

• Good inter-personal skill

• Good communication skill in English

• Must have excellent knowledge of cGMP & Regulatory agency & guideline (USFDA, WHO,EU-GMP, EMA, MHRA, TGA, ANVISA, ICH, PIC/S)

Opsonin Pharma Ltd. is one of the pioneers in the pharmaceutical industry of Bangladesh. At present Opsonin is enjoying its position as the fastest growing organization among the Top Four Pharmaceutical companies in Bangladesh. Currently we are seeking application from qualified professionals for the position of-

• Job Location: This position is located at the factory of Opsonin Pharma Ltd. in Barishal

Major Job Responsibilities:

• Dispensing of raw material as per SOP and ensure storage condition RM & Finished goods.

• To give line clearance & approval before starting of manufacturing and packaging operation.

• In process testing/check in every stages of manufacturing and packaging as per SOP.

• Sampling of in process, bulk & finished product, Process & Cleaning Validation, Hold time.

• On-line checking of BMR/BPR and compilation of batch documents for release of finished product on time. Ensure PV/CV protocol. Collect RT, RTSS & Ongoing stability sample.

• Ensure Document control & Data life cycle management. Over all compliance of Site GMP.

• Prepare, review & update of SOP & archive, retrieve and disposal of QMS documents.

• Handle of Product Complaint & recall, Deviation, OOS, QIR, Change control, QRM, CAPA, NCR & Rejection. Carryout RCA, Investigation, CAPA tracking, trending, review & Closeout.

• Prepare APQR to comply cpK value. Take a part of process Validation to meet CPP & CQA.

• Carry out Internal Audit/Self Inspection, Vendor audit, Environmental monitoring, Utility monitoring, Training & development as per SOP.

• Prepare Dossier as per CTD, ACDT, COPP comprising country specific requirements.

• Opsonin offers excellent work environment, attractive compensation package and performance based career progression.