Head - Analytical R&D
Qualification: Msc in Chemistry / Analytical Chemistry / Biotechnology / Organic Chemistry or Any Life Sciences.
Experience: 8-10 years in Analytical Research & Development with Quality.
- Should be responsible for leading Analytical & Quality.
- Should have a knowledge of analytical method developments & validations, technology transfer, equipment & Instrument validations, shelf life evaluations, formulation analytics and bio analytics.
- Should be responsible for batch manufacturing quality check & assurance with sequential details.
- Should have strong knowledge on operation, calibration & preventive maintenance of Instruments such as GC FID, GC HS, HPLC, GC MS, FTIR, Moisture titrator, IR balance, UV spectrophotometer, AAS, ICP OES, NMR, stability chambers with specific software’s.
- Should be responsible for inter departmental communications for effective developments & ease of operations of all departments.
- Should be very communicative and smart enough to able to present subjects without pause.
- Should have strong knowledge on preparation, review & approval of SOPS, technical documents, MSDS, COA, MOA, Specifications, Monographs, protocols, reports, validation documents, validation reports, reference standard evaluations, Deviations, Change control, CAPA, Quality manual, Internal audit documents, etc., with other QA activities.
- Should have strong knowledge on preparing BMR, BPR, In process quality check, final quality check.
- Ensures that production records are evaluated and signed by designated person. To do this, he/she must evaluate or designate someone to evaluate every batch record in order to satisfy himself/herself that all has gone as it should. He/she will also need to ensure that the documents have been completed correctly.
- Should be responsible for vendor audits & approvals.
- Approval or rejection of materials, e.g. packing materials, intermediates, bulk and finished products, in accordance with specifications.
- Monitoring compliance with GMP & GLP.
- Retention of records. Since both have responsibility for the generation of records relevant to batches, then the arrangements for the storage of those records may be a shared responsibility.
- He should be authorized person is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for human use.
- The authorized person will also be involved in other activities, including the following:
- Implementation (and, when needed, establishment) of the quality system.
- Participation in the development of the company’s quality manual.
- Supervision of the regular internal audits or self-inspections.