Piramal Healthcare Limited A major force in the pharmaceuticals and healthcare segment, Piramal Healthcare Limited, incorporating Healthcare Solutions and Pharma Solutions, has an unequivocal vision – to become the most admired pharmaceutical company, with leadership in market share and profits.
Post: MANAGER PRODUCTION, CHIEF MANAGER/ MANAGER-R&D, MANAGER R&D (ADL), Manager - Quality Control, Manager - Quality Assurance
MANAGER PRODUCTION (210004T8)
Department : Production
Qualification : B.Pharm
Experience : 10+ years in Formulations Pharmaceutical Industries and experience in sugar coated tablets will be an added advantage.
• To plan, review and update the manufacturing, packaging activities.
• To make production plan as per delivery schedule of dispatch.
• Ensure maintenance of area and equipment as per GMP requirements
• To co-ordinate with QA, QC, Stores, HR, IT, EHS and Engg. Department.
• To plan manpower requirement to meet the expected output and delivery schedules by involving concern key person of particular section of department.
• To ensure that Good Manufacturing Practices are followed in the department.
• Review daily production report and manpower utilization report. Reviewing and ensuring correct entries are done in BMR, BPR and GMP documents.
• To plan validation and calibration of various instruments and machines in co-ordination with QA and Engg. Dept.
CHIEF MANAGER/ MANAGER-R&D (210004NW)
Department : Commercial R&D
Qualification : M.Pharm (Pharmaceutics)
Experience : 10-15 years of experience in Tech-transfer, Formulation development and micro-nutrient premixes designing and development, Process optimization and, Literature survey for new product development
1. Formulation development, premixes designing and development, reviewing of Cost Data Sheet (CDS) before forwarding for costing.
2. Co-ordination with Marketing, production, QA, QC and other cross functional teams
3. Literature survey for new product development.
4. Product technology transfer
5. Co-ordination with QA and QC to address market complaint and trouble shooting.
6. Technical inputs for customer support (directly and indirectly through marketing).
7. To communicate customer’s requirement to R&D team and provide technical inputs for new product designing including calculations for vitamins and mineral label claims and respective sources.
8. To generate and compile supporting data for statutory requirements.
9. Documentation of lab trials, analytical reports, samples dispatched, marketing queries, audits and other day-to-day work requirements.
10. To ensure Data Integrity in quality processes
11. Documentation related to Quality Management System/ Environmental Management System Occupational Health & Safety Assessment (ISO 9001:2015, ISO 14001:2015, OSAS 45001:2018).
12. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
13. To implement QEHS policy & objectives
MANAGER R&D (ADL) (210003W5)
Department : Commercial R&D
Qualification : M.Pharm/M.Sc (Analytical Chemistry)
Experience : 8-10 years of experience in Analytical Method Development in Formulations.
• Development & validation of analytical methods.
• Calibration records maintenence
• Assist QA/QC for trouble shoot.
• Analytical method transfer.
• Maintane documents of Lab trials.
• Planning of routin & stability samples.
Manager - Quality Control - (210001EJ)
Department : Quality Control
Qualification : M.Sc Chemistry
Experience : 10+ years of experience in Pharma with hands on experience in RM,PM,FG sections (GLP, OSD, OLD, Nutrition). Knowledge of Microbiology will be an added advantage
• Ensuring analytical and technical support to production and QA to meeting all GMP regulatory requirements. Ensuring the quality and integrity of all GxP data and documentation generated.
• Releases / Rejection of Raw materials / Packing material / In process samples as per statuary requirement.
• Usage decision for Release / Rejection of RM / PM in SAP System.
• Ensure availability of adequate resources (quantity / quality) for QC to maintain compliance with GMP requirements.
• Provide inputs to manufacturing and R&D work process to ensure quality by design.
• Responsible for any additional projects agreed by quality management.
• Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed in a comprehensive manner.
• Define quality control goals and strategy in line with Piramal compliance, Product quality control management objective and regulatory requirements.
• Ensures timely and successfully transfer of Analytical Methods as per the requirements of policy.
• Responsible for designing, implementing and ensuring compliance to all quality control related SOPs at site
• Harmonizing the QC compliant process and policies within the Quality Control.
• Continuous evaluation / maintenance of QC facilities/equipment as per current standard.
• Assure fully Engagement and Involvement of subordinates regarding awareness and clarity related to data integrity and ensure the same.
• Knowledge of EHS – Demonstrates basic knowledge of environment, Health and safety requirements within work area in order to comply to all set standard, identify and escalate potential hazards.
• Investigation Skills – Demonstrates expert knowledge of investigation procedures and tools, domain knowledge, impact assessment and implications on related areas in order to have comprehensive investigation to avoid repeat of issues/incidents, review trends and understand issues impacting organization and design CAPA.
• Collaborations & Trust - Identifies builds and maintains strong and sustainable partnerships based on trust, with different stakeholders across teams and within the team, functions and geographies to meet business objectives.
• Customer Centricity - Reinforces the importance of being customer focused; encourages a culture that values customers while monitoring and acting on their feedback from customers. Always focuses on delivering solutions that meet customers’ need.
• Takes action to promote and implement innovative ideas. Takes initiatives and encourages innovative solutions at work by trying different and novel ways while handling work problems or opportunities.
• Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 111.
• Ensure the 21 CFR Part 11 compliance in the Laboratory.
• Ensuring implementation of effective sanitation activities at all the levels.
• To co-ordinate with external agencies for technical support.
• Ensure the updating of Master specification for RM/PM/FG/SFG in SAP system.
• As a roll of Reviewer, Quality Control SOP reviewed in ENSUR system
• Ensure that the sampling of incoming Raw materials, Packing materials and Microbiological sampling as per current SOP.
• Ensure that the testing of Raw materials, packing materials, In-process Samples & Finished Goods as per STP.
• Ensure Analysis & reporting of stability products as per programmed by QA Section.
• Ensure the daily Calibration of Equipments / Instruments are completed as per SOP.
• Ensure that the QC staff is following and maintaining the practices of cGMP & GLP.
• Ensure the all quality reports, Data / Results entry as per SAP system.
• To organize the preparation and maintain the working standards & documentation as per SOP.
• Investigation, Review and verify the OOS, deviation, change controls with respect to Quality control.
• Ensure that the analysis & reporting of process validation samples are done in time.
• To ensure effective implementation of the Quality management system in Quality control department with respect to laid down procedures and systems.
• To ensure that the critical equipments used for analysis are qualified and in calibrated status.
• To carry out self inspections and ensure compliance to the audit observation.
• To ensure the compliance to the current ISO 9001, ISO 14001, ISO 22000, HACCP and SQF, WHO-GMP, UNICEF and other customer, Regulatory requirements and corporate Guidelines.
• Setting of Quality parameters for the Quality Control Department with interaction with R&D, which includes Specification updating, Technology transfer, Method transfer etc.
• To organize up-gradation of systems like documentation / SOPs / Analytical Services / Training / Budgetary exercises, w.r.t. Quality Control
• Imparting & organizing the Internal / External training activities for Quality control personals.
• To prepare & submit Monthly MIS Reports to Accounts & Quality Assurance dept.
• The procurement of Microbial cultures, Reference standards, Lab chemicals, HPLC columns & Spares for Instruments/ Equipment’s.
• Execution of process validations analysis.
• To monitor the destruction of respective records & Retention Samples of Raw Materials as per due expired schedule.
• Annual Maintenance (AMC) for Laboratory Instruments / Equipment’s.
• The preparation of the budget activity likes CAPEX & OPEX for the current year with respect to Quality control dept.
• To conduct the audits for Vendor and out sourcing laboratories.
• Preparation of Training Calendar and ensure the training imparted to all concern
Manager - Quality Assurance - (210000UM)
Department : Quality Assurance
Qualification : B.Pharm/M.Pharm
Experience : 10+ years of experience in Pharma industry with hands on experience in handling IPQA, QMS, Audit handling skills.
1. To establish, document and implement quality management system, and to ensure effective implementation, monitoring and control of quality management system at manufacturing , packing, testing and warehouse activities with respect to laid down procedures, systems and identify areas for improvement.
2. To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers.
3. To review SOPs, batch manufacturing and packing records, specifications and test methods of the products.
4. To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution.
5. To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guide lines as per quality management system.
6. To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program.
7. To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically.
8. To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures , that each production batch complies with the provisions of Drugs and Cosmetics Act and other legal, customer and regulatory requirements.
9. To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non conformities observed during the audits.
10. To ensure compliance to the current ISO 9000, ISO 14000, D&C Act, PFA Act, NDPS , HACCP , SQF, WHO-GMP, UNICEF and other customer and regulatory requirements.
11. To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility.
12. To ensure completion of APRs of products and take appropriate actions in case of deviations.
13. Recommendation to recall approving authority on product recall, review and disposition of recalled and returned goods.
14. Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition.
15. To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site.
16. To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures.
17. To identify and provide resources with co-ordination with other departments to carry out quality functions effectively.
Job Location : Mahad, Raigad Distrct, Maharashtra
Last Date : 10th December, 2021
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