159 Bpr Jobs

The Production Chemist will be responsible for executing and monitoring API manufacturing processes, ensuring compliance with cGMP, SOPs, and regulatory guidelines . The role involves operating chemical process equipment, documentation, troubleshooting, and process optimization to achieve efficiency, safety, and quality standards. Key Responsibilities & Duties: Process Execution: Perform batch manufacturing activities in line with Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and cGMP requirements. Equipment Operation: Operate and monitor reactors, centrifuges, multi-mill, shifter, tray dryer, filtration systems, GLR, and SSR equipment . Quality Assurance & Compliance: Coordinate with QA/QC teams for batch release, deviation handling, and ensure adherence to regulatory and quality standards . Documentation: Maintain accurate production records, logbooks, and deviation reports ensuring data integrity and audit readiness. EHS & Safety Compliance: Follow Environmental, Health & Safety (EHS) protocols, participate in safety drills, and ensure a safe work environment. Process Optimization: Assist in scale-up, yield improvement, and continuous improvement initiatives for cost-effective production. Troubleshooting & Maintenance: Identify and resolve equipment or process deviations in coordination with the engineering and maintenance teams . Shift Management: Supervise shift operations, allocate tasks, and ensure smooth production workflow. Qualifications & Experience Education: B.Sc./M.Sc. in Chemistry or B.E. in Chemical Engineering. Experience: 1 - 6 years in API production / pharmaceutical manufacturing . Technical Skills: Knowledge of GMP, GLP, ICH, and regulatory compliance . Hands-on experience with clean room operations, batch documentation, and shift planning . Familiarity with process safety, scale-up, and validation activities . Preferred Attributes Strong analytical, problem-solving, and decision-making skills . Ability to work effectively in a fast-paced, regulated production environment . Good communication, teamwork, and reporting skills . Flexible to work in shifts and handle multiple tasks.

Oversee QA For Contract Manufacturing: Draft Agreements, Review Batch Docs, CoAs, Deviations, And Artwork. Ensure GMP Compliance, Traceability, And Regulatory Alignment. Support IPQA Checks, Sampling, Audits, And Real-Time Issue Resolution. Required Candidate profile Skilled in corporate QA documentation, third-party coordination, and artwork review Manage change control, audit readiness, and traceability Ensure regulatory compliance and product release approval

Division Department Sub Department 1 Job Purpose Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation. Key Accountabilities (1/6) Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations Perform calibration, clean and set different equipment and machines as per SOP and schedules for on-time completion of batch processing Check the suitable change part as per product requirement Arrange change parts & stereo for batch packing activity Key Accountabilities (2/6) Operate the packing machines by using minimum resources to get quality product Evaluate the product dimensions and set the machine for changeovers Perform in-process checks in packing machines to ensure proper functioning of machine Perform labelling and handle rejection control in packing machine Reduce micro stoppages and avoid non-conformances during packing machine operations, cleaning and line clearance Maintain equipment, facility and block premises as per SOP for audit readiness and to avoid critical and major observation Perform all operations as per cGMP and safety to reduce rejection Key Accountabilities (3/6) Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP. Fill Machine logs & other relevant documents precisely to meet cGMP requirements Check documentation before submission to ensure data integrity Conduct training related to cGMP, equipment operation, for workmen to minimize deviation from procedure Provide technical support to operators about packing activity and cGMP to get quality output for any up-gradation during packing activity Key Accountabilities (4/6) Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety Perform regular interlock checks of packing machines and perform safe operations Ensure usage and maintenance of PPEs by workmen during shifts Report any near-miss to officer in-charge in time Key Accountabilities (5/6) Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations Provide training to other operators about secondary packing machine settings and operations Conduct training related to safety and housekeeping for workmen Participate in learning of new machine and build expertise in troubleshooting the machines Key Accountabilities (6/6) Major Challenges Meeting shift target due to unavailability of adequate resources. Overcome by efficient work load distribution Maintaining cGMP requirements during system downtime. Overcome by coordinating with engineering and technical support team Low yield due to more rejections. Overcome by controlling rejection and simplification of process and attending training Key Interactions (1/2) Store for daily dispensing plan and availability of packing materials (Daily basis) Engineering for preventive maintenance and help in modification (as per need) Key Interactions (2/2) Maintenance contractor for any machine repairs (Need Based) Dimensions (1/2) Achieve average volume of 60 mn (FY2015-16) Average number of BPR’s handled : 60 Average number of batches in packing : 60 Average number of sales order dispatched : 25 Achieve internal OTIF more than 90% Achieve Zero reportable accidents/ incidences during packing activities Achieve 0% errors in online documentation Meet 100% compliance to SOP and Safety regulation Dimensions (2/2) Key Decisions (1/2) Up-gradation in facility and documents to Section Head - Packing Modification in equipment to Section Head - Packing Deviation and implementation of CAPAs Section Head - Packing Key Decisions (2/2) Education Qualification Diploma (Engineering / Pharmacy) Relevant Work Experience 0-2 years of experience in packing with knowledge of handling of QMS activity, qualification and other related documents

Asst. Manager – External Preparation and Oral Liquid Finished Formulations Location - Paria Pardi Gujarat 10 to 15 Years B. Pharma / M. Pharma with FDA Approval Interested? Share your CV nidhi@iihcrecruiters.com OR Call/WhatsApp +91 73548 88500 Required Candidate profile Equipment qualification (DQ, IQ, OQ, PQ) Validation (HVAC, Water, Equipment, Systems) Regulatory compliance (WHO GMP, PIC/S, EU, MHRA, FDA) Audit handling (Internal, Vendor, Regulatory)

Job Description 1. Preparation and review of operational packing materials list, Packaging materials specifications, Packaging materials specifications base documents, BOM, BPR (PAS X and SAP), In House Labels for Exhibit Batches, Pack Split Up and Pallet Matrix. 2. To provided technical support to Production, QA, QC and RA. 3. Review of Artwork, Shade cards and print proof etc. Initiate Change controls, Deviation and CAPA and close all action item of change control, CAPA and deviation within time frame preparation of investigation report of deviation. Coordinate with R&D and QA for Primary Packaging Materials Specifications, Primary Pack Specification and Standard Test Procedures. 4. Preparation and Review of SOP’s, Protocols and Reports. Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements. Execute and supervise all tasks and activities as per applicable SOP’s. Work Experience 2-4 years Education Graduation in Pharmacy Diploma in Packaging Technology Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for IPQA, line clearance, preventive maintenance checks, BMR/BPR review, vendor qualification, audit support, QAMS documentation, APQR preparation, and compliance verification across departments. Required Candidate profile M.Sc or M.Pharm or BSc or BPharm 2-3 Years 2.5 to 3.5 LPA

1. Monitor raw material dispensing activity. 2. Perform daily IPQA activities as per SOP-defined frequency and ensure timely closure of IPQA observations. 3. Conduct validation sampling as per approved validation protocols. 4. Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy and compliance. 5. Perform ERP-related transactions of IPQA. 6. Check BSR (Batch Summary Record) and Shipper inspection as per SOP. 7. Manage issuance, review, and reconciliation of formats across all departments. 8. Conduct IPQA rounds and share observations with concerned HODs for corrective action and compliance. 9. Ensure cleaning, sanitation, and hygiene in all departments to maintain GMP compliance at all times. 10. Perform sampling of In-process, Semi-Finished Goods (SFG), and Finished Goods (FG) as per procedure. B.Pharm / M.Pharm / M.Sc. in relevant discipline. 2-5 years of experience in IPQA or Quality Assurance within the pharmaceutical industry.

Officer Production, Vapi, Gujarat Responsibilities: Equipment cleaning as per ECR/SOPs Ensure cGMP compliance Execute batch charging (BMR/BPR) Maintain records Complete BMR/BPR/ECR documentation Apply at talent@hireindians.com or call 8882212459. Required Candidate profile Qualifications & Skills: * B.Sc. / M.Sc. in Chemistry (Analytical/Organic/Industrial) or B. Pharma. * 1–4 years of experience in pharmaceutical formulation/API manufacturing.

Walk-in interview For Sun Pharmaceutical Industries Limited, Dadra Date: 14th Sept 25 (Sunday) We are recruiting for our OSD manufacturing facility located at Dadra Time: 10 AM to 4 PM Interview Venue: Sun Pharmaceutical Industries Ltd, Survey No. 694, Dadra - 396193, (U.T. of D & N. H.), India, Following are the requirements for our manufacturing facility at Dadra Location. 1) Designation: Operator / Sr. Officer / Executive / Sr. Executive Engineering Education: ITI / Diploma / B. E (Elect. / E.C /Inst./ Mech) Department: Engineering Experience : 6 8 years of Experience of handling Engineering QMS, OSD Process Maintenance, Engineering Projects, Utility and Water System in OSD manufacturing plant. 2) Designation Operator / Officer / Executive Manufacturing & Packing Education: ITI / Diploma/ B. Sc/ B. Pharm / M. Pharm Department: OSD Manufacturing & Packing Experience: 6 - 8 years of work experience in pharmaceutical company, handling Granulation, and Primary & Secondary Bottle Packing activities in a regulated OSD manufacturing plant. 3) Designation: Technician Warehouse Education: ITI / Diploma Department: OSD Warehouse Experience: 4 - 8 years of work experience in pharmaceutical company handling Raw Material & Packing Material Dispensing in Warehouse in a regulated OSD manufacturing plant. For all the positions, we are looking for candidates with experience in regulated plants like USFDA, MHRA, ANVISA, TGA etc. Interested candidates meeting with criteria should carry their updated resume along with photograph, Photocopy of Salary Supporting/Appointment/latest Increment letters giving salary breakups of Monthly & Annual Salary is must.

Role & responsibilities Perform daily IPQA activities and line clearance in the manufacturing facility. Conduct training for IPQA and production personnel regarding IPQA activities. Review and update artwork/shade cards as per proposed Change Control Note (CCN) details. Oversee language translation processes for documents such as quotations, PR, PO, and final artwork. Monitor plant critical areas for GMP compliance. Prepare and review GMP documents, including SOPs, protocols, and other relevant records. Review executed batch manufacturing/packing records, COA, and analytical data. Manage control sample handling and review stability sample management procedures for compliance. Participate in process validation and cleaning validation activities. Oversee non-conformance handling and ensure compliance in consultation with department heads. Ensure compliance with all QA and plant procedures. Review key documents such as Master Batch Manufacturing Records (BMR/BPR), Master Formula Cards (MFC), QC Specifications,Stability Study Reports, and Annual Product Quality Review (APQR). Support internal and external audits and ensure compliance with audit observations. Ensure fulfillment of all regulatory and market-specific requirements related to products. Ensure compliance with GMP regulations as per ISO, WHO, and CMDCAS standards. Preferred candidate profile Bachelor's or Masters degree in Pharmacy/Science or a related field. Minimum of 3-5 years of experience in IPQA activities within the injectable pharmaceutical industry. Strong knowledge of GMP, ISO standards. Experience in handling regulatory audits, deviations, CAPA, and change control procedures. Proficiency in documentation and compliance procedures related to pharmaceutical manufacturing. Excellent communication, analytical, and problem-solving skills.

As a Trainee Executive in the Packing Section with a requirement of 2 years of experience, your main responsibility will be to manage and schedule the packing plan for various products across different sections. This includes efficiently allotting manpower for packing tasks and ensuring that the packing is carried out effectively. You will be expected to report all activities to the senior management and prepare documents such as Batch Manufacturing Records (BMR) and Batch Packing Records (BPR). It is essential to achieve the targets set for the Packaging Section and have a comprehensive understanding of Current Good Manufacturing Practice (CGMP). Furthermore, you should be familiar with facing Good Manufacturing Practice (GMP) audits.,

Senior Executive QA 1 Post based in Kathua, Jammu & Kashmir The ideal candidate brings 8-10 Years and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO) Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus

Quality Assurance Pharmacovigilance (PV) Specialist based in Hyderabad. The ideal candidate brings 3-5 and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO). Provide QA oversight to PV operations including ICSR processing, signal detection, RMP, PSUR/PBRER quality checks, compliance to GVP modules, and CAPA closure after audits. Additional info: Position Summary: Ensure highest PV standards. Responsibilities: QA oversight across AE reporting, signal detection, risk management; audits per GVP; safety document review; monitor FDA/EMA/ICH/WHO frameworks; lead CAPA; deliver PV QA training; align Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Senior Officer QA 3 Posts based in Kathua, Jammu & Kashmir. The ideal candidate brings 4-6 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO). Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

Senior Officer QA (QMS) 1 Post based in Kathua, Jammu & Kashmir. The ideal candidate brings 4 - 6 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments. Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety. The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen). Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO).Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment. Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus.

The ideal candidate brings 2 yrs exp and a strong record of GMP/cGMP compliance within regulated pharma, chemicals or biotech environments Key responsibilities include ownership of day-to-day operations, documentation integrity, SOP creation/review, deviation/OOS handling, CAPA and change control management, audit readiness, cross-functional coordination with Production, QC, Engineering and Supply Chain, and proactive risk assessment to protect product quality and patient safety The role requires hands-on problem solving, stakeholder communication, coaching junior staff, and contribution to continuous improvement (5S/Lean/Kaizen) Strengthen QMS: author/review SOPs, BMR/BPR, oversee IPQA/AQA, batch release readiness, data integrity ALCOA+, vendor qualification, and regulatory inspection support (USFDA/EMA/WHO) Must demonstrate strong ownership, attention to detail, and the ability to work in a fast-paced, inspection-ready environment Familiarity with ICH, WHO TRS, ISPE, and data integrity principles is expected; hands-on with spreadsheets/ERP/LIMS is a plus

Designation - Sr. Executive / Asst. Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Ahmedabad Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 6+yrs. and above Required Candidate profile Company coming up with Greenfield Project Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

As a Digital Solutions Consultant at Worley, you will have the opportunity to work collaboratively with a diverse and inclusive team to deliver complex projects for our clients. Worley, a global professional services company specializing in energy, chemicals, and resources, is at the forefront of bridging the gap towards more sustainable energy sources while meeting the current societal needs for energy, chemicals, and resources. In this role, you will be responsible for supporting strategic initiatives, contributing to continuous improvement efforts, adhering to governance structures, and assisting in reporting tasks. We are looking for a candidate who is eager to learn, open to feedback, and ready to grow within the organization. Your responsibilities will include understanding and contributing to project management and business processes, providing ideas for strategic planning, supporting senior staff in implementing strategic initiatives, and striving for high-quality performance with continuous improvement initiatives. The ideal candidate for this position should possess a Bachelor's degree or Master's degree in a related field, along with 3-7 years of work experience. Excellent communication and teamwork skills, strong problem-solving abilities, and a willingness to think innovatively are key attributes we are looking for. We value individuals who are eager to learn and grow within the organization and who can contribute positively to our diverse and inclusive workplace culture. If you have experience in Agile, Scrum Master, Digital Strategy-Road maps, Digital Process, DPR, BPR, or come from a Consulting or Business Analyst background, you are encouraged to apply. This role requires an individual contributor who is ready to take on challenges and drive innovation and sustainability in our projects. At Worley, we are committed to creating a workplace where everyone feels empowered, respected, and heard. We are actively working on reskilling our workforce to become experts in today's low carbon energy infrastructure and technology. Join us to explore diverse opportunities and be part of delivering sustainable change without any barriers to your potential career success.,

Title: Executive API Custom Field 2: 2806 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Preparation and Review of Standard Operation Procedures, Review of executed BMR, BPR, ECR, etc, Responsible for Change control management, Preparation and Review of Annual product review, Responsible QA Release, Responsible for Process Performance Qualification and Cleaning Validation, Handling of Deviation, Responsible for OOS, OOT investigation related to manufacturing, Responsible for reviewing of Line Clearance activities, Responsible for Finished product sampling Job Segment: QA, Quality Assurance, Technology, Quality

Roles and Responsibilites 1.In process Quality Assurance activity in Production and warehouse area 2.Provide line clearance as per SOP 3.Monitoring and QA rounds in production and Warehouse 4.Sample verification against TRF / BPCR 5.Carry out Semi-finished / finished product sampling for release, stability study and control samples 6.To send samples along with TRF to Quality control laboratory 7.Participate in media fill, process validation, cleaning validation activities as per requirement 8.Timely communication and co-ordination with all the stake holders 9.Participation in Change control, Deviation & Investigations as per requirement 10.Preparation / review of documents like; SOPs, risk assessment report and any other document as per requirement 11.Timely review of Batch Process & Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data 12.Timely review of executed batch records and associated data 13.Keep vigilance on production operations 14.Review of Analytical Reports as per requirements 15.Participation in Audits & Compliance activity 16.In addition of above, any other responsibility assigned by Superior / HOD 17.Final release of critical intermediate and drug substance batches in LIMS and SAP 18.Risk assessment preparation and review 19.Draft MFR/BPCR/BPR review Qualification Required B. Pharm / M. Pharm Relevant skills / Industry experience 2-10 Years with Injectables or Biotech Induastry in IPQA department

Officer Production, Vapi, Gujarat Responsibilities: Equipment cleaning as per ECR/SOPs Ensure cGMP compliance Execute batch charging (BMR/BPR) Maintain records Complete BMR/BPR/ECR documentation Apply at talent@hireindians.com or call 8882212459. Required Candidate profile Qualifications & Skills: * B.Sc. / M.Sc. in Chemistry (Analytical/Organic/Industrial) or B. Pharma. * 1–4 years of experience in pharmaceutical formulation/API manufacturing.

Seeking a IPQA Executive to ensure skincare products meet regulatory, safety & quality standards. Work closely with manufacturing, R&D, and QC teams. Requirement: 2+ years of QA experience, preferably in cosmetics or pharma manufacturing. Required Candidate profile Skincare manufacturing & QC expertise Knowledge of FDA, GMP, ISO regulations Attention to detail & procedural compliance Strong analytical, problem-solving & com skills Ability to work with GMP proces

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. Position Transformation Manager, GDS PAS Tax, India Rank Manager Education: Any Masters or Bachelor's Degree. PMP/Agile/Prosci or other relevant certification preferred. Experience: Minimum 12-15+ years strong work experience in a consulting environment and proven track record as a program &/change manager leading large scale global and/or client projects. Job Purpose: EY is a global leader in Assurance, Tax, Consulting, Strategy and Transaction Services. We develop, implement, and integrate our services, solutions, products, and people expertise to better serve our clients and build a better working world. The People Advisory Services (PAS) is a sub-service line of Tax focused on people management, assisting our clients in global mobility, HR/mobility transformation, reward management, and much more. The working world is changing faster than at any time before. Entire industries are disrupted, and companies need to think strategically and embrace change or be left behind. EY Global Delivery Services (GDS) is a dynamic and truly global delivery network playing a vital role in EY's All In strategy. The PAS team at GDS works side-by-side with the firm's partners, clients, various subject matter experts, and technology team in developing domain-led, technology-enabled services and solutions that enhance value, improve efficiencies, and enable our people, business, and clients with disruptive and market-leading services and products. We are currently seeking a Transformation Manager with experience in Program/Change and Process Management within the GDS Strategic Transformation Team (STT). We are looking for highly motivated individuals with excellent problem-solving and management skills with a genuine passion to make things happen in a dynamic organization. The ideal candidate will collaborate closely with Business Initiative Leaders and Engagement Leads across the organization, managing various transformation projects for GDS and our wider global network clients. The role also involves establishing, maintaining, and strengthening stakeholder relationships. Key Responsibilities: - Demonstrate technical competence and take a practical, business-driven approach to solving complex business and client challenges as part of the strategic initiatives. - Deliver high-quality project outcomes and receive exceptional feedback from clients and global project counterparts. - Independently create value for clients by leveraging strong project, process, and change management skills, along with past client experiences. - Apply consulting best practices and techniques to all work undertaken. - Conduct rapid assessments of the client's current landscape, providing insights, hypotheses, and solutions. - Lead or support the seamless delivery of project/program/change outcomes. - Develop and manage a knowledge repository for use across projects. - Able to influence and persuade clients and stakeholders to gain support for any major change initiatives or decisions. - Encourage and facilitate collaboration among team members, promote an inclusive working environment. - Play an active role in counseling and mentoring junior consultants within the organization. - Support the development of collateral, tools, techniques, and methodologies to enhance transformation programs and the broader capability offering within the practice. Preferred Skills and Characteristics: - Program Management/Change Management and Process Methodology expertise such as: Agile, Scrum, Waterfall, Prosci, Lean, BPR, etc. - Strong presentation skills coupled with conceptual, critical, and consultative thinking abilities. - High levels of integrity, energy, agility, adaptability, and work ethic. - Proven experience in cross-functional collaboration and the capacity to work effectively both independently and as part of diverse teams in a dynamic, global setting. - Experience supporting a range of Transformations in a Program, PMO, Project, or process lead role from strategic design to implementation as part of a globally distributed team. - Expertise in a change management role to lead change strategy and visioning, communication strategy, change impact and business readiness assessment, stakeholder management and engagement to drive business readiness and business adoption. - Experience in process discovery or design, process analysis, process documentation and implementation, process measurements, process monitoring, and optimization. - Expertise in application of agile, hybrid, standard project methodologies to deliver outcomes. - Experience in facilitating virtual and in-person workshops and conducting stakeholder interviews/surveys. - Experience with set up and management of PMOs and working knowledge of project management tools and applications like MS Projects, SharePoint, Microsoft Planner, AHA, ADO, etc. - Excellent working knowledge of MS Office Applications, including Word, Project, Excel, and in particular PowerPoint. - Experience in working with data using analytics/statistical tools such as PBI, Spotfire, etc. - A willingness to share and build knowledge and experience with others in a learning environment. What We Offer: - The chance to work with a global team of experts in a leading professional services organization. - A challenging and rewarding role in a dynamic and international work environment. - Opportunities for personal and professional development. - Competitive salary and benefits package. - A supportive and collaborative team culture. How to Apply: If you meet the requirements and are ready to take on this exciting role, please submit your CV highlighting your relevant experience. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Join us in our mission to deliver exceptional services and shape the future with confidence. We look forward to your application! EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

Lead and optimize sterile injectable production, ensuring cGMP compliance, timely delivery, and continuous improvement GMP compliance, planning, output/yield/OEE monitoring, team management, audits, BMR/BPR approval, coordination with QA/QC,

Role & responsibilities 1. Documentation Issuance & Control - Issue Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks to production as per SOP. - Maintain master documents for BMR, BPR, SOPs, and other controlled documents with proper version control. - Implement and maintain document control systems as per GDP and cGMP requirements. 2. Batch Record Review & Compliance - Review executed BMR and BPR for completeness, accuracy, and compliance with approved specifications. - Coordinate with production to resolve discrepancies, deviations, and documentation errors. 3. SOP & Change Control - Assist in preparation, review, and revision of SOPs related to QA and documentation practices. - Support change control, deviation, and CAPA processes related to documentation. 4. Audit & Regulatory Support - Ensure readiness for internal and external audits by maintaining accurate documentation. - Provide necessary documents and records during inspections (USFDA, WHO, MHRA, etc.). 5. Training & Coordination - Train production and QA staff on Good Documentation Practices (GDP) and documentation SOPs. - Coordinate with other departments for timely closure of documentation requirements. 6. Data Integrity & Archiving - Ensure compliance with data integrity principles in all document handling activities. - Maintain systematic archival of controlled documents for easy retrieval and regulatory compliance.