Post: Site Head/ Works Manager /APIs and Intermediates Manufacturing Facility.

Experience:Minimum 15 -20 years

Location: Paithan, Aurangabad

Qualification B.E. (Chemical) / M.Sc

Job Description

• To provide the leadership with a capacity of site head for smooth functions of plants.
• To meet the manufacturing targets within the norms and budget
• To establish, implement and maintain quality management and associated system.
• To ensure all the section heads are executing their responsibilities – review daily, weekly, monthly, quarterly planning and budgeting.
• To ensure compliance of systems including regulatory and customers’ requirements.
• To coordinate between production, Engineering, Quality Control, Quality Assurance, Warehouse and Dispatch department for smooth functioning of the site.
• To interact with external agencies on technical matter including customer’s representatives, regulatory authorities, certification bodies etc.
• To provide support in evaluation of techno/commercial feasibility of new products.
• To provide support/ guidance for successful transfer and scale up of new technologies for commercialization.
• To provide both technical and managerial guidance to the team members.
• Responsible to operate the plant as per EHS norm.

Post : Head of Product Development & Scale Up

Location :Position is based in Paithan, Aurangabad.

Experience Minimum 10 -12 years

Education : PhD/ M.Sc - Organic Chemistry with around 10-12 years of experience in Pharmaceutical API Companies.

Responsibilities

Individual will lead a team of Production chemists from Production Team, Scale-up & Technology Transfer & Projects. Candidates should have experience in Product Development, with experience in producing cost-effective, non-infringing, safe and eco-friendly technologies for the synthesis of reliable APIs and intermediates.

Job Description:

• To lead a team of Production chemists from the Production Team for the Pilot Batches, Scale-up & Technology Transfer and Projects
• To develop and produce cost-effective, non-infringing, safe and eco-friendly technologies for the synthesis of reliable APIs and intermediates.
• Creative capabilities in the areas of organic chemistry in designing and conducting multi step organic synthesis that is very much attractive from commercial aspects,
• To Identifying and select API molecules based on developing Non-infringing process for API molecules
• Support in transformations in synthetic organic chemistry aimed at target molecule from the Pilot scale to Plant scale.
• Good skills in interpretation of NMR, Mass spectra,, IR, GC, HPLC and XRD.
• Strongly self motivated, believing in team work and efficient problem solver, having good skills for development of subordinate potentials.
• Exhibit Good Laboratory Practice.
• Efficient handling of High pressure, Hazardous, Highly moisture sensitive and other specialized reactions.
• API- cost effective process development.
• Optimizing the process by considering the yield, quality, cost and safety operations of the process.
• Data generation for DMF filing of final APIs.
• Preparation of Process Development Report/TTD to transfer technology .
• Impurity impact on process, identification & synthesis
• Development of new API molecules and technology transfer of the same.
• Process improvement for cost reduction and easy technology transfer.

Post: HOD /Manager/ QA-QC/API.

Experience:Minimum 8-10 years

Education: M.Sc Analytical Chemistry

Job Responsibility

Analysis:

• Raw material / packing material / solvents analysis at the time of incoming
• In process analysis.
• Finished product analysis and compare to require specification compliance

Manage QC lab

• Method validation – Set test methods as pharmacopoeia and GMP requirement.
• Instrument calibration: Prepare calibration Schedule and calibration as per schedule.
• Properly execute actual testing done as per SOP.
• Manpower arrangement and set shift setting as per shift Schedule.

Training*

• Prepare training schedule with help of HR Department.
• Well inform to related department in 2 days prior through mail and by phone.
• Provide training as per schedule.
• Training effectiveness and re train if require.

Trend Analysis

• Trend analysis of basic raw material.
• Finished product trend for all tests.
• Water analysis tends.
• Investigation for out of trend if found.

Batch release:

• Review analysis report and release hold the batch if any non-conforming found.

To get pharmacopoeia monographs of latest edition within 2 months after launch the Edition Authorities

QA/QC Manager will be authorised to:

• To allocate and carry out RM/PM/Online analysis and pass or reject the same if quality doesn’t matches as per the requirements.
• To prepare and implement Quality Policy in consultant with senior management.
• On receipt of any customer complain will be responsible to prepare CAPA after investigation.
• Maintain the QC Lab and effective usage of lab Instruments, calibration process Validation & analytical testing related activity with MIS and cGLP practices.
• Prepare daily MIS and Monthly MIS.

QC activities as below,

• Prepare specification for analysis
• Hold time study
• Microbiological sample collection and monitoring of fumigation activity.
• Suggest and provide guidance to the shop floor if microbiological counts are increased.

Other Responsibilities:

• Responsible for Documentation work in QC & QA Department
• Responsible for manufacturing the batch as per MOM or BMR.
• Shall maintained all records related to manufacturing
• To ensure the compliance of safety Requirement, Cleanliness Hygiene and Environment in Working Areas.
• Responsible for Domestic / Export/ batch production & their Documents for their smooth Dispatch Activity.

Post: Executive–Procurement/ Purchase.

Experience: Minimum 3-4 years

Location: Thane, Mumbai

Responsibilities

• Responsible for sourcing of all raw material, solvents, fine chemicals & packing material.
• Dealing with existing vendors and developing reliable vendors or suppliers to source the quality goods at competitive price.
• Negotiate with vendors to optimize profitability.
• Ensuring timely deliveries as per plan.
• Manage the supply chain of all material purchased.
• Should have thorough knowledge and handled raw material, solvents, fine chemicals & packaging material for the Pharmaceutical products.
• Coordinate with quality and warehouse departments to monitor everyday activities of units and ensure the efficient working
• Manage all work in terms of inventory forecasting and management to ensure, there is no shortfalls of the ram materials, solvents, fine chemicals and Packing material.
• Coordinate with the Works Manager and evaluate the ways to reduce cost and improve the supply chain management.
• Develop and maintain professional relationships with all external vendors and contractors and improve efficiency process through incorporation of new technology.