Technology Transfer Manager Harman Finochem

10.0 - 17.0 years

2 - 4 Lacs

Aurangabad

Work from Office

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Posted 1 month ago

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Asst. Manager / Dy. Manager Formulation Development Molkem Chemicals

6.0 - 8.0 years

7 - 9 Lacs

Ahmedabad

Work from Office

Role & responsibilities Review and approve product test license, Import license for RLD and API. Review and approve standard operating procedures (SOPs) of equipment, instruments & facilities. Plan and execute reverse engineering of RLD and marketed products. Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products. Plan and optimize formulation for Injectable dosage forms. Compile, review and approve technical documents, including Formulation Development and Stability study protocol reports. Plan and perform stability studies to ensure formulation meets stability requirements. Compile, review and approve API, Formulation stability reports. Ensure compliance with regulatory documents and company quality standards. Coordinate with Analytical, Regulatory, Stores, Purchase, Project management and Development Quality Assurance teams to support product development and regulatory submissions. Maintain laboratory equipment and ensure proper calibration and maintenance. Participate in technology transfer activities to manufacturing sites. Prepare FD lab for agency audits and customer visits. Other roles and responsibilities assigned by the FD Manager and R&D Head. Preferred candidate profile Master's degree in Pharma or related field Must have 06 - 08 years of Experience in Formulation Development Must have 04 - 06 years of team handling role in R&D Centre

Posted 2 months ago

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