21 Aug
|
Samyojak Consultancy Services
|
Goa
21 Aug
Samyojak Consultancy Services
Goa
Job Overview :
A leading global contract development and manufacturing organisation (CDMO) specializing in nutraceutical and pharmaceutical products is seeking an experienced Production Senior Executive to oversee and support manufacturing operations while ensuring compliance with cGMP, regulatory, quality, and safety requirements. The role involves production execution, documentation management, equipment qualification and maintenance, process validation activities, SAP transactions, batch record review, and coordination with cross-functional teams to ensure efficient and compliant production of pharmaceutical and nutraceutical products. The ideal candidate will possess strong technical knowledge of manufacturing processes, documentation practices, regulatory requirements, and production systems within a pharmaceutical manufacturing environment.
Job Responsibilities:
- Execute manufacturing and packaging activities in accordance with approved procedures, cGMP requirements, and regulatory standards applicable to target markets.
- Maintain and review production documentation, including BMRs, BPRs, SOPs, templates, records, qualification documents, and online quality system documentation.
- Operate and monitor production equipment involved in mixing, rolling, scoring, coating, inspection, blister packing, printing, and related manufacturing processes.
- Perform and coordinate equipment qualification, calibration, verification, maintenance activities, and ensure timely reporting of equipment breakdowns or maintenance requirements.
- Participate in process validation, cleaning validation, qualification activities, and manufacturing of validation batches.
- Verify dispensing of raw and packaging materials,
manage return of excess materials to the warehouse, and process material rejections where required.
- Ensure accurate status labeling of products, equipment, containers, trays, and production stages throughout the manufacturing process.
- Collect, document, and submit intermediate and finished product samples to Quality Control for analysis.
- Handle SAP transactions and maintain accurate production records in accordance with assigned roles and system authorizations.
- Ensure compliance with cGMP, Good Documentation Practices (GDP), safety requirements, statutory regulations, and company quality standards.
- Support deviation investigations, change controls, non-conformance reporting, CAPA activities, and communicate quality-related observations to Quality Assurance.
- Monitor cleanliness and maintenance of production equipment and manufacturing areas in accordance with approved schedules and procedures.
- Train and guide production personnel on operational procedures, compliance requirements, safety practices, and documentation standards.
- Collaborate with Quality Assurance, Quality Control, Warehouse, Engineering, and other departments to ensure efficient and compliant production operations.
- Support departmental improvement initiatives and assist management in strengthening production systems and regulatory compliance.
Job Requirements:
- B.Pharm or M.Pharm qualification is mandatory.
- 5–10 years of experience in pharmaceutical or nutraceutical manufacturing operations.
- Strong knowledge of cGMP guidelines, Positive Documentation Practices (GDP), regulatory requirements, and pharmaceutical manufacturing processes.
- Experience in production documentation, BMR/BPR preparation and review, and electronic documentation systems.
- Hands on experience in process validation, cleaning validation, equipment qualification, and calibration activities.
- Familiarity with manufacturing, packaging, dispensing, and material handling processes in regulated environments.
- Experience in handling deviations, investigations, change controls, CAPA, and compliance-related activities.
- Working knowledge of SAP and production related system transactions.
- Understanding of production equipment operation, maintenance coordination, and troubleshooting practices.
- Strong leadership skills with experience in training, mentoring, and supervising production personnel.
- Excellent organizational, analytical, and problem solving abilities.
- Good communication and interpersonal skills with the ability to work effectively across departments.
- Ability to maintain strict adherence to quality, safety, and regulatory standards.
- Candidates with prior experience in pharmaceutical manufacturing facilities operating under international regulatory requirements will be preferred.
Benefits:
- Company provided transportation facility.
- Canteen facility.
Location : Cuncolim, Goa
For any further details please write to us on
📌 Senior Production Executive - Pharmaceutical Industry (Goa)
🏢 Samyojak Consultancy Services
📍 Goa