18 Apqr Jobs

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

3+ years of hands-on CMC experience required with JMP for statistical analysis, including DoE(Design of experiment), statistical approaches: PCA, and PLS. Strong understanding of QbD, PQR, and regulatory guidelines (ICH/FDA) required. Proficiency in SAS/R programming is essential Software: Minitab and JMP

Role & responsibilities In-Process Monitoring : Monitor and evaluate the manufacturing or production processes in real-time to ensure compliance with quality standards and specifications. Sampling & Inspections : Conduct regular inspections, sampling, and testing of raw materials, in-process goods, and finished products to ensure quality control is maintained at every stage. Documentation & Reporting : Maintain accurate records of in-process quality checks, test results, and production data. Report any deviations, non-conformities, or issues to the production team and management. Training & Support : Provide guidance and training to production staff on quality standards, best practices, and regulatory requirements. Compliance : Ensure that the production process meets relevant industry standards and regulatory guidelines, such as FDA, ISO, or others as required. Preferred candidate profile Experience with SAP or similar ERP software systems for quality documentation and process management. Knowledge of in-process quality control techniques, statistical methods, and testing protocols. Interested Candidates can share their resumes at Anee.Silas@otsukapharma.in

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed Qualification documents of equipment & instruments 12 Stability studies documentation with help of Quality control. 13 Preparation & Revision of SOPs of Quality Assurance department. 14 Compliance and preparation of Audit Report. 15 Maintenance of control sample room & Documentation room. 16 Training of sub ordinates & evaluation. 17 Preparation of Training schedule and its implementation and monitoring. 18 Identification of training needs to internal/ external to the sub ordinates. 19 Compliance of Audit Report from Government authorities (FDA). 20 Any other activity assigned by the management.

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Develop & update SOPs, ensure compliance, prepare MSDS/specs, review BMRs, check COAs/labels, maintain documentation, conduct training, perform audits, and support corrective actions to uphold quality standards across operations.

Desired Candidate Profile 2-5 years of experience in Quality Assurance & Compliance role in API manufacturing industry. MS/M.Sc(Science) degree in Chemistry Strong understanding of GMP & Regulatory Compliance, Document Control & SOP Management, APQR, CAPA & Market Complaint Management.

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

1. COA/ Certificate of Analysis 2. MSDS 3. Specifications/ TDS 4. Method of Analysis 5. Stability Data 6. DMF/ Drug Master File 7. Declarations B. Preparation of Vendor Questionnaire Required Candidate profile C. Customer response for technical queries D. Must have knowledge of Pharmacopoeias, ICH guidelines Intrested Candidate Can connect on 91-9724346949 / 9327657730

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Key Responsibilities: Review and verify quality-related documents and procedures. Handle change control, deviations, and impact assessments. Manage incidents, investigations, and CAPA implementation. Oversee market complaints, product recalls, and mock recalls. Prepare and review SOPs, validation protocols, and reports. Ensure compliance with batch manufacturing and packing records. Monitor shop floor activities for quality assurance. Implement and manage quality control processes. Perform other tasks as assigned by management. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma Industry : Pharmaceutical Formulation/API Experience: 06 - 11 Years Role: Sr.Officer/Executive Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

• Responsible for QA activities & review of documents in the area of: • Quality Management Systems, Incidents & Investigations, IPQA, Internal Audits • Document control • Batch review and release, Dispatch • Validations, Qualifications • Product Quality review • Logging, Investigating and closing Quality events (Deviations, OOS&OOTs, Complaints), Participate in Investigations • Logging, Tracking, Closing Changes, CAPAs • IPQA and Internal Audits • Document Management – Issuance, Retrieval, Archival • Review of Quality System documents such as -Batch records, Validation reports, Qualification reports, calibration reports • Review Dispatches and documentation • Review Vendor Qualification, • Coordinate Training Management, Samples dispatch • Sampling of intermediate/ APIs

Roles and Responsibilities Conduct vendor audits, root cause analysis, and deviation management to ensure compliance with quality standards. Prepare SOPs for QMS implementation and maintain accurate records of market complaints, CAPAs, and change controls. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Ensure timely completion of tasks related to APQR (Advanced Product Quality Review) and participate in continuous improvement initiatives. Maintain a high level of accuracy in data entry, documentation, and reporting.

Role & responsibilities You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company. Key Deliverables: 1. Ensure manufacturing practices as per cGMP and GLP standards. 2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc. 3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.) 4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits. 5. Ensure all personnel are trained on requirements for GMP, GLP, GDP, applicable regulatory issues and other procedures related to their work area. (SBG) 6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers. 7. Assisting HOD in customer complaint analysis and preparation of customer complaint report. 8. Investigation of incidents, deviations, OOS and ensure corrective actions in place. 9. Reviewing the daily availability of operators and allocating work to them. 10. Maintaining and review BMR documents, guide for relevant changes if required. 11. Label artwork review and management. Technical Competencies: a) Analytical skills (spotting trends and patterns) b) Report writing skills c) Problem solving abilities d) GMP and GDP knowledge e) Good English communication skills (verbal & written). Behavioural Competencies: a) Quality and Service Orientation b) Delivering consistent results c) Ability to prioritize, organize, manage work and time. d) Customer Centric e) Cross Functional Team Working Preferred candidate profile B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology) 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries. Perks and benefits 1. Opportunity to be part of a growing organization offering niche products to Pharma industry. 2. Opportunity to work at Head Office location. 3. Intimate small company culture with MNC professionalism. 4. Company value programs TrANSSCEnD. 5. Employee events like festival celebrations, family fun events etc. 6. Five days working (alternate weeks). 7. Medical Insurance for your immediate family. 8. Housing accommodation for Bachelors & family.

About Us: Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality & most affordable medicines across the nation. The company is having 1st Rank (Unit wise sales) in Gujarat state since more than 17 consecutive years as per ORG IMS. In addition to this, the company is ranked 82 among top companies of India (Rupee wise sales) MAT December 2021. Website : www.unisonpharmaceuticals.com We are seeking specialists for multiple roles into Quality Assurance at our EU Approved OSD Manufacturing facility at Unit I Moraiya, Ahmedabad. Company : Unison Pharmaceuticals pvt ltd. Location : Unit I (Moraiya, Ahmedabad) - Transportation provided from Ahmedabad routes (1) Quality Assurance - Validation Designation: Sr. Executive /Assistant Manager /Dy. Manager Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 8 to 12 years Job Exposure required: Must Have : Process Validation, Cleaning Validation Preferred to have: QMS, Risk Management, Qualification (2) Quality Assurance - Compliance & Training Management Designation: Executive / Sr. Executive Education Qualification: B.Pharm/M.Sc/M.Pharm Experience Required: 6 to 10 years Job Exposure required: Must Have : Audit Compliance, Training Management (3) Quality Assurance - Documentation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 7 Years Job Exposure required: Must Have : APQR or IPQA & Batch Record Preparation (4) Quality Assurance - Process Validation Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 5 to 8 Years Job Exposure required: Must Have : Process Validation, Hold Time Study (5) Quality Assurance - IPQA - Packing Designation: Officer / Sr. Officer / Executive Education Qualification: B.Pharm/M.Sc/M.Pharm/B.Sc Experience Required: 4 to 8 Years Job Exposure required: Must Have : In process QA , Line clearance of Packing area Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Exciting Career Opportunity at Hetero (Annora Pharma) Pvt Ltd! We are conducting a MEGA Walk-in Drive @GOA for our Formulation Units in Hyderabad. If youre looking to grow your career in the pharmaceutical industry, dont miss this chance to join one of India’s leading pharma companies! Open Positions: 1. Production • Qualification: ITI / Diploma / B.Sc / B. Tech / B Pharm • Experience: 1–6 years • Designation: Operator / Jr. Officer / Officer / Jr. Executive / Executive • Areas: Granulation, Compression, Coating, FBP, QMS, Capsule filling 2. Quality Control • Qualification: M Pharm / B Pharm / MSc • Experience: 1–6 years • Designation: Jr. Officer / Officer / Jr. Executive / Executive • Areas: Stability, HPLC, GC, Wet Analysis, IP/FP, RM, LIMS, Microbiology 3. Quality Assurance • Qualification: M Pharm / B Pharm / MSc • Experience: 1–6 years • Designation: Jr. Officer / Officer / Jr. Executive / Executive • Areas: IPQA, QMS, Market Complaints, AQA, Qualifications, APQR Walk-in Interview Details: Date 1: 24th May 2025 (Saturday) Venue: The Fern Kesarval Hotel & Spa, Verna, Goa Date 2: 25th May 2025 (Sunday) Venue: Boshan Hotels, Mapusa, Goa Job Location: Hyderabad Timings: 09:30 A.M. to 04:30 P.M. Please Bring: • Updated Resume • Education Documents • Last 3 Months’ Payslips • Appointment Letters, CTC Breakup, ID Proof (Aadhar/PAN) For more info, contact: chandrasekhar.r@hetero.com | pavani.ar@hetero.com Cell 9010203989 We look forward to seeing you there!