71 Who Jobs - Page 2

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Pharm / M.Pharm with 8 to 10 years of experience in Regulatory Affairs. To Review dossier prepared by executives & trainees & submit to client along with artworks for countries like ASIA, LATAM & ROW Market. Follow up with FRD & Microbiology Dept. Required Candidate profile Ensure that a company's products comply as per current ICH & Country Guidelines. To work on Renewals of Registration Certificate for countries. Courier of Legalized Documents such as COPP, FSC, POA. Perks and benefits Negotiable - Depending Upon Candidate & Experience

Female B.Pharm / M.Pharm with 4 to 6 years of experience in Regulatory Affairs. Dossier Preparation in CTD/ACTD/Country Specific Formats. Re-registration and Renewal Application. Variation Application, Queries Handling, DMF Activity & Artwork Review. Required Candidate profile Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan & Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder, Gel & Cream, Injections, Syrup, Oral Drops Perks and benefits Negotiable - Depending Upon Candidate & Experience

Job TitleSA LocationMumbai / Pune Skill- End to end KYC, Periodic Review, AML, and Due Diligence Shift Timings:APAC , EMEA , NAM Roles & Responsibilities This role will include the understanding and implementation of the KYC lifecycle. He/she would be responsible for opening, amending, reviewing and exiting clients according to established policies and procedures, and also review clients transactions to detect and report either proposed or completed unusual transactions. Key responsibilities include: Performing the due diligence on new Clients, requesting the KYC information, documentation, review and verification of received documentation and making an analytical risk assessment for new Clients Thoroughly and succinctly document the research and analysis related to the financial activity and related entities of Clients Escalate issues to client and internal managers to bring issues to their attention promptly Independently handle clients and client calls establish self as a valued partner Help knowledge management endeavor by sharing process knowledge and best practices within the teams Communicate effectively and efficiently with relevant internal and external parties to obtain KYC documents Have a thorough understanding of the clients business and related parties to monitor clients activities for unusual transactions Perform further investigation on identified suspicious client and clients transactions and report to KYC/AML compliance officer Qualification and Skills Bachelors Degree (B.Com, BBA, BBM, BCA) / Masters Degree (M.Com, MBA, PGDM). 2 to 4 years of experience and knowledge of KYC, AML, and Due Diligence Should be able to understand, manage and calculate risks Should be good with logical and quantitative abilities

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: In-Process (IP) Responsibilities: Perform line clearance and IP checks during manufacturing and packaging activities. Monitor critical process parameters during granulation, compression, coating, filling, and packing. Verify BMR/BPR entries and ensure Good Documentation Practices (GDP). Collect and test in-process samples as per approved specifications. Report and escalate any deviations, non-conformities, or abnormal observations. Finished Product (FP) Responsibilities: Sample and submit finished product batches for QC testing. Coordinate with the QC department for timely testing and release of finished goods. Ensure FP storage conditions and labeling are as per SOPs. Assist in reviewing batch records and supporting batch release activities. Coordinate with warehousing for approved and rejected batch segregation. Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Microbiology, or relevant field. 13 years of experience in QA or QC, preferably in formulations or oral solid dosage manufacturing. Key Skills: Good understanding of cGMP, GDP, and regulatory compliance (USFDA, WHO, MHRA, etc.). Knowledge of production processes and quality checkpoints. Strong documentation, observation, and communication skills. Familiarity with QMS tools like deviation, change control, and CAPA (optional but preferred). Ability to work in shifts and in a fast-paced environment.

Key Responsibilities: Prepare and execute validation protocols (IQ, OQ, PQ) for equipment, facilities, and utilities. Conduct cleaning validation and revalidation studies, including swab/rinse sampling and microbial testing coordination. Perform process validation (PV) activities for new and existing products. Coordinate with cross-functional teams (Production, QC, Engineering, R&D) for validation execution and troubleshooting. Review and update validation master plans (VMP), protocols, and reports as per regulatory requirements. Ensure calibration and qualification records are up to date and compliant. Maintain documentation in compliance with data integrity and ALCOA+ principles. Support audits and regulatory inspections by providing validation documentation and clarifications. Track and monitor validation schedules and ensure timely completion. Stay updated with latest regulatory trends, validation guidelines, and industry best practices (ICH Q8, Q9, Q10, Q12). Qualifications: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Microbiology, Chemistry, Biotechnology) or related field. 25 years of relevant experience in validation within a pharmaceutical or healthcare manufacturing setup. Knowledge of cGMP, WHO, USFDA, EU, and other regulatory requirements. Key Skills: Sound knowledge of validation principles, risk assessment, and lifecycle approach. Proficiency in drafting validation protocols and technical documentation. Experience with computerized system validation (CSV) is an advantage. Good analytical, problem-solving, and organizational skills. Effective communication and ability to work in a team.

: Job titleBond Analytics Analyst Corporate titleAVP LocationBangalore, India Role Description OverviewBusiness Division Deutsche Banks Corporate Bank (CB) a market leader in cash management, trade finance & lending, securities services and Trust & Agency Services. Focusing on the treasurers and finance departments of corporate and commercial clients and financial institutions across the globe, our universal expertise and global network allows us to offer truly integrated and effective solutions. OverviewBusinessTrust and Agency Service (TAS): With offices in New York, California, London, Frankfurt, Milan, Lisbon, Dublin, Hong Kong, Singapore and Tokyo, the Trust and Agency Services team at Deutsche Bank has long been recognized as a leader in the provision of administrative and fiduciary services to the global debt and equities markets. It supports structures from the simplest to the most complex, covering Asset Backed Securities, CLOs and Managed accounts, Corporate Debt, Escrows, Project Finance, Loan Agency, and Depositary Receipts. OverviewTeam: TAS Analytics group within Corporate Trust business of Deutsche Bank is supporting the Structured Finance products like ABS/MBS/CDOs and other Debt products like Syndicated Loan transactions where DB acts as Trustee and/or Agent. As Trustee and/or Agent, DB is responsible for performing various calculations including but not limited to Bond Payments and Tax Calculations for new and existing bond issuances. Group has exposure to Corporate Trusts business in understanding the Structured Finance and other Debt products and its Analytics requirements along with supporting the CSG activities. The successful candidate will be required to cover European working hours supporting the EMEA/Americas business. Corporate title will depend on the relative experience of candidate. What well offer you 100% reimbursement under childcare assistance benefit (gender neutral) Sponsorship for Industry relevant certifications and education Accident and Term life Insurance Your key responsibilities Read and interpret governing legal and issuer documents namely Prospectuses/Offering Circulars, Bond Indentures and Pooling and Servicing Agreements, Hedging Agreements, etc. Process and review Bond Payments for MBS, ABS, CDO and similar kinds of structured product deals in an In-House platform (iMAKE) based on the Offering Circulars/Indenture/Pooling & Servicing Agreement and using the best practices followed in the Group. Offer the highest level of customer service by understanding overall deal structure and bond payments to provide internal and external clients with explanations to support cash flow model output. Establish the guidelines for receipt and appropriate format of underlying asset-level collateral that supports bond payments, as well as research and resolve any data accuracy issues. Involvement in ad hoc/special projects which support process improvement and the implementation of technology initiatives. Understand and analyze issues and offer practical solutions. Working independently with a minimal degree of supervision is required to exercise independent judgment. Your skills and experience Bachelor of Science/Engineering or qualified CA/CFA with a high GPA and a minimum of 2 years of professional experience. Previous experience in developing cash flow models, and exposure to securities industry. Must have proven skills in MS Excel and/or MS Access with good scripting skills in VBA. Experience in using SQL Demonstrated ability to handle multiple and often competing projects under tight deadlines and pressure. Must project a Customer/Client service focus. Responsible for supporting efforts to mitigate and control operational risk. Must be organized, focused, and possess strong communication and analytical skills. Demonstrated ability to work and think independently, while supporting team goals/objectives. How well support you About us and our teams Please visit our company website for further information: https://www.db.com/company/company.htm We strive for a culture in which we are empowered to excel together every day. This includes acting responsibly, thinking commercially, taking initiative and working collaboratively. Together we share and celebrate the successes of our people. Together we are Deutsche Bank Group. We welcome applications from all people and promote a positive, fair and inclusive work environment.

Job Summary: We are looking for an experienced Production Manager specializing in External Preparations (ointments, creams, gels, lotions, topical solutions, etc.) and Liquid filling line to manage and optimize pharmaceutical production activities. The successful candidate will have proven experience operating under WHO GMP, PICS GMP & EU GMP and will be responsible for ensuring high standards of quality, compliance, and efficiency in product manufacturing. Key Responsibilities: • Production Manager for oversees the manufacturing processes related to external preparation formulations & Liquid filling line. • Production Planning & Execution Develop and implement production schedules to meet demand while ensuring efficiency. • Compliance & Quality Assurance – Ensure adherence to GMP, WHO, and EU GMP regulatory guidelines for external preparations / Liquid filling. • Process Optimization – Improve manufacturing processes for better yield, consistency, and cost-effectiveness. • Equipment & Facility Management – Oversee the maintenance and validation of equipment used in manufacturing and packing. • Documentation & Reporting – Maintain batch records, SOP, and Logbook for manufacturing and packing line. • Troubleshooting & Problem-Solving – Address production issues, deviations, and implement CAPAs as needed. • Oversee warehouse operations, including inventory management and logistics. • Maintain accurate records of inventory and warehouse activities. • Co-ordinate with engineering teams in designing, developing, and maintaining systems or products. • Coordinate with Quality Assurance, Quality Control, Engineering, and Warehouse teams to ensure seamless operations. • Ensure equipment is properly maintained, calibrated, and qualified; plan preventive maintenance schedules in collaboration with engineering. Qualifications & Experience: • Degree in Pharmacy, Pharmaceutical Technology or related field. • 7+ years of hands-on experience in pharmaceutical manufacturing, with 3+ years in external preparations / Liquid filling. • Strong knowledge and practical experience with WHO GMP, PICS GMP, and EU GMP regulatory requirements. • Familiarity with manufacturing equipment and technologies specific to external preparations / Liquid filling. • Experience in managing inspections/audits by international regulatory agencies. • Strong leadership, organizational, and communication skills. • Fluency in English.Role & responsibilities

* Having an instrumental and wet lab. * Experience of GC -HPLC & all Lab Instruments * Documentary work, SOP preparation activity * ISO, GMP, FDA, WHO Audit Faced. Required Candidate profile * Attention to detail and accuracy * Documentation and report writing skills * Ability to work in a team and under regulated environments

• Having an instrumental and wet lab. • Manpower handling. • Experience of GC -HPLC & all Lab INSTRUMENTS. • Documentary work, SOP preparation activity. • ISO, GMP, FDA, WHO Audit Faced

Quality Manager Pharmaceutical Manufacturing Department: Quality Specialist Reports to: Director Job Summary: We are seeking a highly competent and detail-oriented Quality Manager to lead the Quality Assurance and Quality control functions at our pharmaceutical manufacturing site. The successful candidate will bring deep knowledge of WHO GMP, PICS standards, and EU GMP regulatory expectations, ensuring full compliance and continuous improvement of the Quality Management System (QMS). Key Responsibilities: • Lead, manage, and continuously improve the Quality Management System (QMS) to ensure full compliance with WHO, PICS, and EU GMP regulatory requirements. • Oversee GMP compliance, including batch record review, deviation management, CAPAs, change control, product release, OOS, OOT and risk assessments. • Act as the site representative during inspections and audits (WHO PQ, EU GMP, PICS, clients), including preparation, hosting, and follow-up. • Supervise and mentor QA / QC teams responsible for documentation control, training, and GMP compliance. • Develop and implement cleaning validation, Process validation, Equipment qualification and utility qualification activity. • Review and approve critical quality documents such as SOPs, protocols, reports, and validation master plans. • Oversee the vendor qualification and quality agreements with external suppliers, service providers, and contract manufacturers. • Lead internal audits and support continuous quality improvement initiatives. • Collaborating with cross-functional teams to ensure quality throughout the product lifecycle. • Developing and implementing quality control systems. • Monitoring performance of quality control processes. • Analyzing quality data to identify areas for improvement. Qualifications & Experience: • Bachelors or Masters degree in Pharmacy, Pharmaceutical Sciences, Biotechnology, or related life sciences field. • Minimum of 8 years of pharmaceutical quality experience, with 3+ years in a managerial or leadership role. • In-depth knowledge of WHO GMP, PICS guidelines, and European regulatory requirements. • Strong experience leading audits/inspections from international authorities (e.g., WHO, PICS, EU) • Excellent analytical, leadership, and interpersonal skills. • Fluent in English

Job Description Candidate should the exposure for handling the Bottle packing line. Should have the work experience in Regulatory plant. Faced the USFDA, MHRA,TGA inspection. Good Communication skill. Having the SAP knowledge. Work Experience 3 to 05 years' Experience. Education Graduation in Pharmacy Competencies

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at N-32, Additional Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

Job Description: Head of Quality Experience: 15 Years or more Location: Udaipur About Macsen Drugs: Macsen Drugs is a USFDA registered, WHO-GMP certified, TGA GMP certified, and EU GMP (Written Confirmation) certified manufacturer of active pharmaceutical ingredients or bulk drugs for varied therapeutic applications like antidote, urinary antiseptic, topical antiseptic, ophthalmic diagnostic, anti-dandruff, anti-acne, and several other applications. Job Overview: We are seeking an experienced and detail-oriented individual to perform research activities as designing and conducting scientific experiments, analyzing and interpreting results, leading to significant value to the process development. Efficient contribution to the overall success of the research & development team performance according to objectives and targets set by the Management. Responsibilities: 1. Quality Assurance (QA) Develop and implement a comprehensive Quality Management System (QMS) compliant with cGMP and ICH guidelines. Review and approve quality documents such as SOPs, batch records, deviations, and CAPA reports. Ensure the site is prepared for regulatory audits and inspections from the USFDA, EMA, WHO, and other agencies. Conduct internal audits and self-inspections to maintain quality standards. 2. Quality Control (QC) Oversee laboratory operations, ensuring raw materials, intermediates, and finished products meet established quality specifications. Manage analytical method validations and stability studies. Monitor calibration and maintenance of laboratory instruments. 3. Regulatory Affairs Prepare and submit regulatory documents, including DMFs, for US and international markets. Address regulatory queries and implement corrective actions for observations from audits or inspections. Stay updated on global regulatory trends and ensure compliance with evolving requirements. 4. Production Oversight Collaborate with production teams to ensure manufacturing processes align with quality standards. Oversee cleaning and process validation for a multi-product facility to prevent cross-contamination. Troubleshoot production and analytical challenges in coordination with R&D. 5. Data Integrity and Security Ensure compliance with 21 CFR Part 11 for electronic records, signatures, and data integrity. Establish protocols for data security and governance across all quality operations. 6. Cross-Functional Coordination Work with R&D and Analytical Development Labs for seamless technology transfer and method development. Collaborate with Stores and Maintenance teams to ensure proper inventory management and equipment validation. Coordinate training programs for team members to maintain high-quality standards. 7. Leadership Lead and mentor teams across QA, QC, Regulatory, Production, and Maintenance departments. • Foster a culture of quality, accountability, and continuous improvement. 1. Educational Qualifications Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related scientific field. Additional certifications in Quality Management Systems (e.g., ISO 9001, Six Sigma) are preferred. 2. Experience Requirements Minimum 15 years of experience in API manufacturing, with at least 5 years in a leadership role managing QA, QC, and Regulatory Affairs. Proven experience in handling audits and inspections by regulatory agencies such as USFDA, EMA, WHO, or PICS. Hands-on experience in managing multi-product facilities with cleaning and process validation expertise. How to Apply: Send your updated resume to hrd@macsenlab.com