Executive, Compliance / Analytical Assurance (Kaliakoir Plant)
Job Description
Title: Executive, Compliance / Analytical Assurance (Kaliakoir Plant)
Company Name: Square Pharmaceuticals Ltd.
Vacancy: Not specific
Job Location: Gazipur (Kaliakair)
Employment Status: Full-time
Educational Requirements:
∎ M. Pharm / B. Pharm (Professional) / MS in Chemistry / Applied Chemistry / Biochemistry & Molecular Biology / MS in Microbiology (From reputed Universities)
Experience Requirements:
∎ At least 2 year(s)
Job Responsibilities:
∎ Job Descriptions for Compliance:
∎ Ensuring proper Data Integrity (DI) related issues
∎ Conducting & Managing Self-inspection/ Internal Audit
∎ Managing & Ensuring proper documentation for Regulatory / External Audit and Compliance
∎ Handling & Reviewing of ANDA submission related documents, Compendia and Guidelines updates
∎ Identifying the gaps and non-conformances in GMP areas/ activities and to take CAPA
∎ Handling and Review of investigation reports (Deviation, QIR, OOS, OOT, Complaints, etc.)
∎ Preparing SOP, Training Modules and Presentation on Guidelines, Compendia or Articles and conduction of training
∎ Job Descriptions for Analytical Assurance:
∎ Reviewing the Protocols and Reports related to Analytical Method Validation/ Verification and Transfer
∎ Reviewing and verifying the Raw Data and Meta Data related to testing of Raw Materials and Finished Products
∎ Reviewing the Specifications and Test Methods
∎ Reviewing and verifying the Working Standard, Chemical Reference Substance, Column and Instruments Calibration related documents and data
∎ Handling Compendia, Guidelines updates, laboratory QMS
∎ Establishing In-house systems and procedures to ensure cGLP practices & regulatory requirements for analytical activities & Participating in troubleshooting (related to testing and instruments)
Additional Requirements:
∎ Age at most 33 years
∎ Minimum 2 years' of relevant experience is mandatory
∎ 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
Salary: Negotiable
Job Source: Bdjobs.com Online Job Posting.
Application Deadline: 17 Nov 2022
Company Information:
∎ 8 Nov 2022
∎ Square Pharmaceuticals Ltd.
Category: Medical/Pharma
