ResponsibilitiesQuality & NABH Compliance Incident & Risk Management Statutory & Regulatory Coordination DNB Coordination Experience3-5 years of experience in hospital quality management Experience with NABH standards, audit processes, and documentation Familiarity with BMC liaison work and statutory licensing Hands-on involvement in DNB inspections

Qualification & ExperienceQualifications for Casualty Medical Officer: PG/ Fellowship in Emergency Medicine MBBS with experience in Emergency Medicine. Qualifications for Resident Medical Officer: MBBS freshers MBBS with 2-3 years of experience will be given preference.

ResponsibilitiesPerforming and organizing timely analysis of raw material, bulk product, intermediates, finished goods and other samples for Pharmaceuticals. Performing and organizing analysis of market complaints, Stability, process validation, Cleaning Validation samples of Pharmaceuticals. Good Laboratory Practice Performing and organizing calibration / maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Reviewing pharmacopeias for specification preparation. Preparing SOPs, Formats, Specification, Analytical Test Record and other documents. Managing reference standards, working standards, Laboratory chemicals & reagents. Managing instrument laboratory with reference to spares, maintenance etc. Managing Control Samples and related record. Approval / Rejection of Raw Materials, Packaging materials, in process materials, Bulk Finished products and bulk medical device. Investigating out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data and log book related to testing activity. Responsible for reviewing the chromatographic data.Qualification & ExpeirencePost Graduate in Science (Organic or Analytical Chemistry) or B.Pharm/M.Pharm 5-7 years in chemical & instrumental testing laboratory with exposure to GMP, GLP

ResponsibilitiesImplementation of Zentiva Global Quality & Regulatory policies & guidelines, review and approval of GxP Documents e.g. Quality Manual, SOPs, Process Validation reports, Master Batch Records, Finished Product specifications, Master Documents, etc. Submission to regulatory authorities associated with various regulatory requirements, authoring / or coordinating RA activities for new registrations / licenses, post approval changes, renewals, GMP Certification applications, annual reports and line extensions to meet requirements.Coordinating and contributing to responses to Agency queries and performing quality review of regulatory submissions.Coordination for cGMP Training activity including training of identified people.Review and approval of Artwork / Labelling.Qualification & ExpeirencePostgraduate in Pharmacy Experience 10 years in Pharma industry with awareness of Quality management systems, Analytical testing, Method Development/Validation, Manufacturing activities, Process validation, Qualification, Regulatory requirements.

ResponsibilitiesQuality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Collection and evaluation of PQRs and stability data Compliance evaluation of Third Parties and products Maintenance of product database Collection and review of CoA/CoC QA support of product launches and transfers GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations Auditing Prepare audit and audit plans Conduct and participate to external audits Evaluation of audit reports Participate to internal audits and inspections KPI monitoring and reportingQualification & ExpeirenceUniversity degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements Management of subcontractors is an advantage Proven track record of project management skills Strong communication skills and negotiation strength

ResponsibilitiesEnvironment monitoring Aseptic area behaviour and monitoring Handling of Instrument i.e NVPC and MAS. Personnel monitoring Trend analysis and reporting Sample handling Qualification & ExperienceQualification: M.Sc (Microbiology) / B.Pharm Experience: 6-9years EM monitoring in aseptic process area including Grade A,B,C and D

ResponsibilitiesRequest corrections when GMP rules are not respected (D) Prioritize quality and compliance objectives (A) Proactively implement remediation action from findings from internal and external audits related to quality issues (D) Request quality improvement initiatives and strategies (D) Identify discrepancies and corrective/preventive actions that need to be taken (D) Escalate to upper management any failure in GMP execution on shopfloor (I) Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I) Advise on how to present a topic and answer specific questions (A) Advise on risk management strategies and plans (A) Advise on initiatives to promote a quality-focused culture (A)Qualification & Experience5-7 years of experience in quality assurance within the pharmaceutical industry. Bpharm/ Mpharm. Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles

ResponsibilitiesComplaints Handling Review of complaints related to ExM which are received for various suppliers. Review the adequacy of investigations and coordinate with internal and external stake holders for closure. Ensure proper investigation tools used as per requirements. Adequacy of CAPA Processing complaints in Veeva system, Trackwise. Trending Periodic trending of market complaints Providing adequate actions for the observed trends and follow-up actions. FAR and Market Action Knowledge on FAR and market action. Able to support for FAR and Market actions triggered through complaints. Any other responsibilities as assigned by the supervisor from time to time. Qualification & ExperienceM.Pharm / M.Sc. (Science), Minimum 06 - 10 years of experience in pharmaceutical industry Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, Market complaints handling Knowledge on Compliance Standards and Regulation as applicable to the market. Hands on experience on Veeva or Trackwise systems

ResponsibilitiesTechnical documentation such as batch records, protocols, and technical reports. Planning, preparation, and execution of scale?up batches, transfer batches, new product launches, and validation batches with end?to?end documentation compliance. Coordination with cross?functional teams. Support to the Regulatory Affairs team by providing technical documentation and responses required for regulatory submissions and variations. Ensuring strict compliance with GMP guidelines, safety procedures, and regulatory requirements in all operational activities. Hands?on experience with TrackWise and SAP for quality events, materials, and documentation management. Active involvement in Change Control, Deviations, Investigations, CAPA, and Out?of?Specification (OOS) handling, including root cause analysis and closure.Qualification & ExperienceExperience in MS&T about 3-4 years. Qualification : B.Pharm/M.Pharm Experience in: New submissions & launches Material change Site transfer activities Scale up & process validation documentation and execution. Handling of Trackwise & SAP.

Responsibilities Quality Control Laboratory Handling all the Quality Control Laboratory operations in compliance with Good Laboratory Practices and Safety policies. Selection, upgradation, procurement, installation and qualification of laboratory instruments and equipment. Preparing and monitoring of Capex and Revenue budget for laboratory. Preparation and execution of cost improvement plans for the laboratory expenses. To identify the needs and to provide resources, adequate facility required for effective and efficient functioning of the department for timely analysis of samples.  Quality Management Oversees the implementation of Standard Operating Procedures relating to the laboratory activities and compliance with the requirements of Good Laboratory practices. Upgradation of laboratory systems as per the regulatory requirements. Oversees calibration and preventive maintenance of laboratory instruments and equipment as per schedule, in accordance with approved Standard Operating Procedures. To arrange vendor assistance for AMC and other Instrument/ equipment breakdown. To ensure upkeep and maintenance of all laboratory standards as per written procedures and to arrange the Laboratory standards based on forecast and priorities. Responsible for monitoring the activities pertaining to upkeep and maintenance of Narcotics and controlled substances.  Stability Study To ensure identification, tracking and Co-ordination of all stability batches packed at Goa site and at other approved packing site. Responsible for activities related to stability management. To ensure planning, supervision and review activities of Commercial Stability Study Samples, Hold Time study Sample, Temperature Excursion, and Thermal Cycling.Qualification & ExperienceBachelor or Master of Science / Pharmacy 15 – 20 years of experience in the Pharmaceutical Industry handling QC operations