Title: Executive/Senior Executive – Product Development (QA)
Company Name: Delta Pharma Ltd.
Vacancy: --
Age: 25 to 35 years
Job Location: Kishoreganj (Pakundia)
Salary: Negotiable
Experience:
Experience candidates will be considered as an added advantage.
Assist in assurance and enforcement of GMP in production facilities.
On-time Management of Compliance activities.
Excellent communication in English (Written & Verbal) and Interpersonal skills.
Efficiency, flexibility, high level of professionalism and ability to work under pressure.
Positive work ethics and result-oriented for assigned responsibilities.Should be self-driven and hardworking.
To be able on computer literacy (MS Word, Excel and Internet Browsing, etc.).
Perform analytical method validation (assay, dissolution, related substances, content uniformity, etc.) in compliance with ICH Q2(R1/R2) and DGDA requirements.
Support and execute process validation activities, including protocol preparation, execution, data review, and validation report preparation.
Conduct and review raw material analysis (API, excipients, packaging materials) as per approved specifications and pharmacopeial standards (USP, BP, EP).
Handle stability study sample analysis, including long-term, accelerated, and ongoing stability as per ICH Q1A(R2) guidelines.
Participate in product development and technology transfer activities, ensuring smooth scale-up from pilot to commercial batches.
Prepare, review, and maintain quality documentation such as validation protocols, reports, SOPs, STPs, and analytical worksheets.
Ensure GMP compliance during development, validation, and routine analytical activities in accordance with DGDA and WHO GMP guidelines.
Assist in investigation of OOS, OOT, deviations, and change control related to product development and analytical activities.
Coordinate with Production, Quality Control, Regulatory Affairs, and R&D teams for development progress, validation scheduling, and issue resolution.
Support regulatory submissions by providing validated analytical data, stability summaries, and development documentation as required.
Ensure proper handling, storage, and documentation of stability samples, reference standards, and working standards.
Participate in internal audits, self-inspections, and regulatory inspections, providing technical support and necessary documentation.
Additional duties as assigned by the superior.
Benevolent Fund
Dormitory Facilities