We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Consultant - Regulatory Affairs" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below:Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts.Role & responsibilities: The person will be responsible for Regulatory consulting services at the firm. The responsibilities of this position include, but are not limited to, the following:Ownership for assigned regulatory projects including dossier writing, submissions, approval tracking, query resolution across Developed markets (UK, Australia, EU and US) and Emerging marketsEnsure regulatory compliance, accuracy, timely completion, version control & adherence to internal SOPsProviding strategic input to the Management and Partners on regulatory projectsKeep abreast of new developments in regulations across all critical health authorities Experience & Qualifications Regulatory affairs experience in small molecules for a minimum of 3-8 years is mandatoryMust be well versed with ICH CTD guidelines and other regulatory guidelines from developed markets (US, EU, UK etc).Must have hands-on experience in regulatory submissions pertaining to generics/ small molecules (m1-m5 CTD writing for EU, Australia and other markets)CEP/ DMF/ ASMF filing with a good knowledge of EDQM requirements would be advantage. Experience in biologics/ biosimilar filings will be an added benefit.Computer and technical skills (including eCTD software knowledge) Strong & Flawless communication skills.Accuracy and attention to detail. Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.comIn case of a query, please feel free to speak to the undersigned:Sudhir Vinayak,Director, Pharma Placements Inc.Mobile: 98202 34987 / 81307 24980

We have been retained by a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development to hire a "Junior GMP Consultant - QC & QA" to be based at their HO located at Navi Mumbai. Details of the position are mentioned below:Company: Our Client is a reputed Pharmaceutical Consulting firm working in the area of GMP, Global Regulatory Affairs & Product Development. They have their head office in Mumbai and subsidiaries in Europe, Singapore, Australia and Malaysia. They have been providing high quality & credible consulting services to the Pharmaceutical Industry in India and internationally. They have a young and committed team of GMP and Regulatory Experts.Role & responsibilities: Adequate experience and well versed with Quality Control and Quality Assurance systems and procedures in accordance to regulatory standards. Hands on experience in handling HPLC, GC, UV, FTIR, etc., worked on LIMS, audit trail, CSV , familiarity with GMP, GLP, EUGMP and ICH guidelines, Should have exposure working in formulations like oral solids dosage form (OSD), injectables, etc.Experience:Min 5-10 years experience in quality control & Quality Assurance in pharmaceutical industry.Knowledge & SkillsCandidate should have exposure working in QC/QA laboratory in Regulated companies. Well versed with Quality Management systems/procedures Thorough knowledge of testing Raw materials, finished product, Packing materials and handling of key instrumentation like HPLC (auto sampler), GC, dissolution testing.Well versed with QC systems & procedures, audit trail review of HPLC, GC and have knowledge of computer system validation related to QC instruments. Familiarity with GMP, GLP, EUGMP and ICH guidelines.Familiar with stability management and calibration Well versed in carrying out Analytical Method validation/verification, Analytical tech transfers. Fluency in English and good communication written and verbal. Job responsibility: 1)To assist project lead in reviewing the QC systems, documentation and practices for client. 2) Participate in Supplier audits at various sites 3) Maintaining GMP data base and preparation of SOPs4) Ready to do extensive travelling to visit Client sites and supplier audits (domestic & international)Preferred candidate:Candidates based only in Mumbai/Navi Mumbai will be preferred. 6. Qualifications:Education:A masters degree in Pharmaceutical Sciences or a master's degree in Analytical ChemistrySkills and Competencies:Strong analytical and problem-solving skills.Attention to detail and accuracy in testing and documentation.Proficient in the use of laboratory equipment and software.Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.comIn case of a query, please feel free to speak to the undersigned:Sudhir Vinayak,Director, Pharma Placements Inc.Mobile: 98202 34987 / 81307 24980

We have been retained by a highly reputed and fast growing Pharma Company to hire "Senior Manager- QA" to be based at their plant located at Aurangabad. Details of the position are mentioned below:Company: Our client is a highly reputed and fast growing Pharma Company. Company's products enjoy a very high degree of acceptance from doctors within India as well abroad. The company has their manufacturing units spread across different locations in India. The sales turnover of the company is more than 700 Crores.Designation: Senior Manager - Quality Assurance (Formulation Unit manufacturing Oral Solid, Liquid Oral & Sterile Injectables)Educational Qualification: M.Sc. / M. Pharma Experience: Minimum of 10 to 15 years of experience of handling QA function of a reputed Pharma Company. Besides QA, the candidate must have basic understanding of QC function also. The incumbent shall have the experience of working as Deputy Manager / Manager QA or above level in a reputed Pharma Company for at least 3 yearsJob location: AurangabadThose of you whose profile matches the above mentioned description and will like to apply for this position shall forward their updated profile to sudhirvinayak@gmail.comIn case of a query, please feel free to speak to the undersigned:Sudhir VinayakDirector, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad. Details of the position are mentioned below:Role & responsibilities: Literature search/study and to prepare development trials strategies.Pre formulation study execution.Market/Innovator/reference product characterization.Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies.Execution of process optimization/scale-up batches.Technology transfer activities at site.Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements.Co-ordination with production, other relevant cross-functional departments/teams.Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market.Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc.Preferred candidate profile : Educational Qualification: M. PharmExperience: 12 - 20 Years of relevant experience in a leading Pharma Company.Good Communication & Presentation skillsThose of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.comIn case of a query, please feel free to speak to the undersigned:Sudhir VinayakDirector, Pharma Placements Inc.Mobile number: 98202 34987